RAPID-MEDICAL LTD

FDA Device Registration & Listing · yokneam Northern, IL · Registration 3009957947

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
3009957947
FEI Number
3009957947
Entity Name
RAPID-MEDICAL LTD
City/State/Country
yokneam Northern, IL
Establishment Address
Carmel Building POB337, yokneam Northern 2069205, IL
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Rapid-Medical (Owner Number: 10060398)
Owner / Operator Contact Address
Carmel Building POB337, yokneam, IL-Z 2069205, IL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K230429
PMA Number
N/A

All Registered Proprietary Names

Drivewire 24 Guidewire BraidE Embolization Assist Device Tigertriever 25 Revascularization Device Drivewire 14 LR (previously Columbus 14 LR) Drivewire 14 SR (previously Columbus 14 SR) Tigertriever 13 Revascularization Device Tigertriever 17 Ultra Revascularization Device Tigertriever 17 Revascularization Device Tigertriever 21 Revascularization Device Tigertriever 13 Revascularization Device

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MOF Guide, Wire, Catheter, Neurovasculature Cardiovascular Class 2 870.1330 2024-07-14
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2024-07-14
QZU Temporary Embolization Assist Device, Peripheral Cardiovascular Class 2 870.3325 2024-03-26
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2026-03-15
MOF Guide, Wire, Catheter, Neurovasculature Cardiovascular Class 2 870.1330 2021-01-19
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2021-01-19
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2022-07-26
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2025-11-16
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2023-04-24

Official Correspondent

Ina Gutman

US Agent Details

Kathryn Meintsma Business: Healthroad Legal Pllc Email: kathryn@healthroadlegal.com Phone: (612) 9617541

Related Public Records

Same Entity

Rapid-Medical
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
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
K012534 Advanced Cardiovascular Systems, Inc. HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING 2002-01-24

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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3009121749 ASAHI INTECC HANOI CO., LTD. Hanoi Ha Noi, VN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009957947. Last updated year: 2026. Please use registration number 3009957947 when referencing this establishment in official correspondence.
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