Identity
- Trade Name
- RAPIDTRANSIT FDA UDI
- Generic Name
- Vascular microcatheter FDA UDI
- Device Name
- RAPIDTRANSIT Infusion Catheter Outer Diameter (Distal) 2.3F (0.75 mm) Usable Length 70 cm 2.8F (0.95 mm) .021 Inch (0.5 mm) 30cm Contents: 1 Infusion Catheter and 1 Shape Mandrel. Minimum Guiding Catheter I.D. / Dia. .042 Inch (1.1 mm) FDA UDI
- Model / Reference
- 601-210 FDA UDI
- Description
- RAPIDTRANSIT Infusion Catheter Outer Diameter (Distal) 2.3F (0.75 mm) Usable Length 70 cm 2.8F (0.95 mm) .021 Inch (0.5 mm) 30cm Contents: 1 Infusion Catheter and 1 Shape Mandrel. Minimum Guiding Catheter I.D. / Dia. .042 Inch (1.1 mm) FDA UDI
Identifiers
- Catalog Number
- 601210 FDA UDI
- Primary DI / UDI-DI
- 10886704028314 FDA UDI
- 510(k) Number
- K972518 FDA UDI
- FDA Product Code
- KRA FDA UDI
- GMDN Term
- Vascular microcatheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1210 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vascular microcatheter
Rapidtransit by Medos International Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K972518 also covers:
- PROWLER — Medos International Sàrl
- PROWLER — Medos International Sàrl
- PROWLER — Medos International Sàrl
- PROWLER — Medos International Sàrl
- PROWLER — Medos International Sàrl
- PROWLER — Medos International Sàrl
- RAPIDTRANSIT — Medos International Sàrl
- RAPIDTRANSIT — Medos International Sàrl
- RAPIDTRANSIT — Medos International Sàrl
- RAPIDTRANSIT — Medos International Sàrl
- RAPIDTRANSIT — Medos International Sàrl
- TRANSIT — Medos International Sàrl
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medos International Sàrl
Sources (1)
- FDA UDI ac22e35a-2616-45ff-bb43-bbb059f13e4d 37 fields · synced May 30, 2026