Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015453963

FEI Number

3015453963

Entity Name

CARDIMED ASIA MEDIKAL SANAYI VE TICARET LTD STI

City/State/Country

Maltepe Istanbul, TR

Establishment Address

Cevizli Mah. Tansel Cad., No:12-18 Bulut Plaza D:32-33-34, Maltepe Istanbul 34846, TR

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Cardimed Asia Medikal Sanayi ve Ticaret Ltd Sti (Owner Number: 10060492)

Owner / Operator Contact Address

Cevizli Mah. Tansel Cad, No:12-18 Bulut Plaza D:32-33-34, Maltepe, TR-34 34846, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P150003

All Registered Proprietary Names

WASHER, BOLT NUT Tubes, vials, systems, serum separators, blood collection CATHETER, PERCUTANEO WIRE, GUIDE, CATHETER Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED GAL LIT Catheter, angioplasty, peripheral, transluminal DQY CATHETER, PERCUTANEOUS WASHER, BOLT NUT Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) DYB Oximeter INSTRUMENT, MANUAL, SURGICAL, GENERAL USE Laparoscope, general & plastic surgery Laparoscope, general & plastic surgery Laparoscope, general & plastic surgery CATHETER, PERCUTANEOUS Mesh, surgical, polymeric Fastener, fixation, nondegradable, soft tissue CATHETER, ASSISTED REPRODUCTION ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED BIT, DRILL Endosurgical ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES DYB FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE Mesh, surgical, polymeric CATHETER, PERCUTANEOUS MSD STAPLE, IMPLANTABLE Fastener, fixation, nondegradable, soft tissue CATHETER, UROLOGICAL Electrosurgical, cutting & coagulation & accessories Fixation, pin Catheter, continuous flush Mesh, surgical, polymeric FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE CATHETER, INTRAVASCULAR, DIAGNOSTIC Coronary drug-eluting stent CATHETER, PERCUTANEOUS Accessories, arthroscopic SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAT - Suture, nonabsorbable, synthetic, polyethylene Laparoscope, General & Plastic Surgery, Reprocessed Catheter, Thrombus Retriever Catheters, transluminal coronary angioplasty, percutaneous STAPLE, REMOVABLE (SKIN) Forceps, obstetrical WIRE, GUIDE, CATHETER CATHETER, PERCUTANEOUS CLIP, IMPLANTABLE CATHETER, IRRIGATION DQX CATHETER, THROMBUS RETRIEVER Laparoscope, general & plastic surgery Wire, guide, catheter CATHETER, PERCUTANEOUS DQX CATHETER, INTRAVASCULAR, DIAGNOSTIC CATHETER, PERCUTANEOUS KRD,HCG INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Coronary drug-eluting stent ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES MOTOR DRILL, PNEUMATIC Catheter, intravascular, diagnostic Coronary drug-eluting stent

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2024-11-09
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2024-11-01
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-11-01
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-01-20
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2023-03-09
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2025-06-03
GET	Motor, Surgical Instrument, Pneumatic Powered	General, Plastic Surgery	Class 1	878.4820	2024-11-20
GAL	Suture, Absorbable, Natural	General, Plastic Surgery	Class 2	878.4830	2024-05-02
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2023-06-23
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2023-06-23
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2022-06-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-06-13
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Unknown	Class 3	N/A	2024-12-24
NIK	Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)	Unknown	Class 3	N/A	2024-12-24
KRG	Programmer, Pacemaker	Cardiovascular	Class 3	870.3700	2024-12-24
NVZ	Pulse Generator, Permanent, Implantable	Unknown	Class 3	N/A	2024-12-24
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2024-12-24
NKE	Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	Unknown	Class 3	N/A	2024-12-24
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2022-12-19
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2025-11-25
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2025-11-25
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2024-11-01
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-06-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-10-25
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-08-01
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-05-06
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2024-08-01
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-05-02
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2025-12-25
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-11-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-02-19
NUJ	Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed	General, Plastic Surgery	Class 2	878.4400	2024-02-19
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2024-05-02
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-05-02
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2024-05-02
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-09-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-06-27
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-06-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-10-26
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2025-09-08
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-11-21
NYU	Catheter, Hemodialysis, Implanted, Coated	Gastroenterology, Urology	Class 2	876.5540	2025-06-10
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2025-06-10
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-10-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-02-24
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2025-07-25
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-10-26
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2024-11-09
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2024-11-09
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2022-12-19
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2019-11-08
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2024-11-01
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-11-01
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-02-13
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2025-02-13
NIQ	Coronary Drug-Eluting Stent	Unknown	Class 3	N/A	2025-04-02
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-09-08
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2024-05-02
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2023-10-26
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2019-07-18
NLM	Laparoscope, General & Plastic Surgery, Reprocessed	Gastroenterology, Urology	Class 2	876.1500	2025-03-17
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2024-11-21
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2025-04-02
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2022-02-25
HDA	Forceps, Obstetrical	Obstetrics/Gynecology	Class 2	884.4400	2022-12-19
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2023-10-26
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-02-12
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2025-06-10
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2019-09-27
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2023-03-09
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2024-11-21
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-09-25
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2024-11-09
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-12-24
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-04-22
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2024-03-01
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2026-01-07
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2025-06-17
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2025-06-17
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2024-02-12
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2024-02-12
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2024-02-12
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2024-02-12
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2024-02-12
KFK	Saw, Pneumatically Powered	General, Plastic Surgery	Class 1	878.4820	2024-02-12
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2024-02-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-12-04
NIQ	Coronary Drug-Eluting Stent	Unknown	Class 3	N/A	2024-03-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-12-04
HBB	Motor, Drill, Pneumatic	Neurology	Class 2	882.4370	2024-11-21
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2025-03-07
NIQ	Coronary Drug-Eluting Stent	Unknown	Class 3	N/A	2025-04-03

Official Correspondent

No official correspondent registered.

US Agent Details

Jason Einhorn Business: ADVANCED INVENTORY INC Email: jason@esutures.com Phone: (888) 4162409

Related Public Records

Same Entity

Cardimed Asia Medikal Sanayi ve Ticaret Ltd Sti

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

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K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04

Related Recall Records

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Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015453963. Last updated year: 2026. Please use registration number 3015453963 when referencing this establishment in official correspondence.