Identifiers
- 510(k) Number
- K101361 FDA 510(k)
- FDA Product Code
- LIT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Reeflex Pta Catheter is a catheter, angioplasty, peripheral, transluminal. It is used for peripheral transluminal angioplasty procedures.
The device is supplied with a product code of LIT and is regulated under 21 CFR 870.1250. It has been cleared by the FDA under the traditional 510(k) clearance type, with a decision date of 2010-08-04 and k number K101361.
Frequently asked questions
What is the Reeflex PTA Catheter used for?
The Reeflex PTA Catheter is used for peripheral transluminal angioplasty procedures, which involve widening narrowed or blocked peripheral arteries.
What is the regulatory status of the Reeflex PTA Catheter?
The Reeflex PTA Catheter has been cleared by the FDA under the traditional 510(k) clearance type, with a decision date of 2010-08-04 and k number K101361.
What product code is associated with the Reeflex PTA Catheter?
The Reeflex PTA Catheter is associated with the product code LIT and is regulated under 21 CFR 870.1250.
Is the Reeflex PTA Catheter a single-use or reusable device?
The provided information does not specify whether the Reeflex PTA Catheter is single-use or reusable.
What is the medical specialty associated with the Reeflex PTA Catheter?
The Reeflex PTA Catheter is associated with the Cardiovascular medical specialty.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: REEFLEX PTA CATHETER (K101361) — FDA 510(k) | Innolitics, PTA catheter / balloon ReeFlex™ Clearstream Technologies Ltd, Reeflex Pta Catheter 510 (k) FDA Premarket Notification K101361 ..., PDF ReeFlex R - Which Medical Device
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K101361 | Class II | Active |
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Manufacturer
- Manufacturer
- ClearStream Technologies , Ltd.
Sources (1)
- FDA 510(k) K101361 24 fields · synced Sep 22, 2026