Identifiers
- 510(k) Number
- K110055 FDA 510(k)
- FDA Product Code
- DQY 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 Reflex Guide Catheter is a flexible vascular guide catheter classified under the Cardiovascular device type. It is designed as a tubular conduit to facilitate the introduction and navigation of interventional devices within the peripheral and neurovasculature, ensuring precise delivery of therapeutic tools such as stents.
This catheter is supplied as a single-use, non-sterile device intended for use in venous interventions. It is intended for use in controlled clinical settings, such as catheterization labs, and requires proper sterilization prior to use. The device holds an FDA 510(k) clearance under the DQY product code, with a Traditional review pathway and Substantially Equivalent determination to predicate devices. No specific MRI safety classification is stated in the data.
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: PDF Reverse Medical Corporation K L0 S ReFleXM Guide Catheter APR KMH, K110055 FDA 510 (k) - REVERSE MEDICAL REFLEX GUIDE CATHETER, REVERSE MEDICAL REFLEX GUIDE CATHETER - Innolitics, Reverse Medical Reflex Guide Catheter - Reverse Medical | FDA Reference
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K110055 | Class II | Active |
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Manufacturer
- Manufacturer
- Reverse Medical Corporation
Sources (1)
- FDA 510(k) K110055 24 fields · synced Oct 1, 2026