Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681572

FEI Number

3003263857

Entity Name

Coastline de Mexico SA de CV

City/State/Country

Tijuana Baja California, MX

Establishment Address

Calle Cipres #4, Tijuana Baja California 22115, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

COASTLINE INTERNATIONAL, INC. (Owner Number: 9025146)

Owner / Operator Contact Address

1207 BANGOR ST, --, San Diego, CA 92106, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CrossBow Guide SecurusDLPortSite Closure Device SecurusEP Passer CrossBow Fascial ClosureSystem

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2015-10-15
PUL	Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered	Ophthalmic	Class 2	886.4100	2023-10-27
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2015-11-13
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2018-12-02
OOK	Dermal Cooling Pack/Vacuum/Massager	General, Plastic Surgery	Class 2	878.4340	2014-07-17
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2023-10-13
EOX	Esophagoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4710	2021-07-02
OOK	Dermal Cooling Pack/Vacuum/Massager	General, Plastic Surgery	Class 2	878.4340	2015-05-27
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2014-07-11
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2023-10-26
MLZ	Vitrectomy, Instrument Cutter	Ophthalmic	Class 2	886.4150	2023-10-26
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2021-06-04
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2021-08-06
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2021-08-06
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2018-12-17
HBO	Clip, Scalp	Neurology	Class 2	882.4150	2014-07-11
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2021-10-29
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2021-10-29
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-12-12
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2015-10-15
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2010-07-20
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2019-03-12
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2010-07-19
OOK	Dermal Cooling Pack/Vacuum/Massager	General, Plastic Surgery	Class 2	878.4340	2014-07-17

Official Correspondent

Bryan Blessing

US Agent Details

Bryan Blessing Business: Coastline International Email: bryan@coastlineintl.com Phone: (805) 5500688

Related Public Records

Same Entity

COASTLINE INTERNATIONAL, INC.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
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
K143446	Roche Diagnostics GmbH	Accu-Chek FlexLink Plus infusion set	2015-08-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); 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.

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3007335051	TURON MEDTECH AB	Varberg Halland, SE
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681572. Last updated year: 2026. Please use registration number 9681572 when referencing this establishment in official correspondence.