RAPID MEDICAL INC.

FDA Device Registration & Listing · Southlake, TX, US · Registration 3015531723

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015531723
FEI Number
3015531723
Entity Name
RAPID MEDICAL INC.
City/State/Country
Southlake, TX, US
Establishment Address
445 South Kimball Avenue, Suite 140, Southlake, TX 76092, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Rapid Medical Inc. (Owner Number: 10060780)
Owner / Operator Contact Address
445 South Kimball Avenue, Suite 140, Southlake, TX 76092, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K203592
PMA Number
N/A

All Registered Proprietary Names

NumenFR Detachment System Numen Coil Embolization System Drivewire 24 Guidewire Tigertriever 17 Ultra Revascularization Device BraidE Embolization Assist Device Tigertriever 13 DriveWire 14 LR DriveWire 14 SR Comaneci 17 Comaneci Petit Comaneci Tigertriever 13 Revascularization Device Tigertriever 21 Revascularization Device Tigertriever 17 Revascularitzation Device Tigertriever 25 Revascularization Device Tigertriever Tigertriever 17

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2022-02-23
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2022-02-23
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2024-07-14
MOF Guide, Wire, Catheter, Neurovasculature Cardiovascular Class 2 870.1330 2024-07-14
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2025-11-16
QZU Temporary Embolization Assist Device, Peripheral Cardiovascular Class 2 870.3325 2024-03-26
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2022-07-27
MOF Guide, Wire, Catheter, Neurovasculature Cardiovascular Class 2 870.1330 2022-02-16
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2022-02-16
PUU Temporary Coil Embolization Assist Device Neurology Class 2 882.5955 2022-02-16
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2023-04-24
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2026-03-15
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2022-02-16

Official Correspondent

Ina Gutman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Rapid Medical 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
K951256 Target Therapeutics DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC) 1995-09-08
K150445 Asahi Intecc Co., Ltd. ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) 2015-06-30
K082922 Lake Region Mfg., Inc. FREEWAY AND RAILRUNNER GUIDEWIRES 2008-12-09
K890207 E-Z-Em, Inc. INTERVENTIONAL PRODUCTS - GUIDE WIRES 1989-05-31
K992169 Advanced Cardiovascular Systems, Inc. ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE 1999-10-28

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0030-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015531723. Last updated year: 2026. Please use registration number 3015531723 when referencing this establishment in official correspondence.
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