Vanguard Reprocessed Diagnostic Electrophysiology Catheters
by Vanguard Medical Concepts, Inc. 9 variants
510(k) K012688
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK012688 | Date31 Jul 2002 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NLH
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1220
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Vanguard Reprocessed Diagnostic Electrophysiology Catheters are single-use diagnostic electrophysiology (EP) catheters that have been reprocessed for reuse. These devices are used for temporary intracardiac pacing and recording during EP studies, featuring a 5-7 French, 95-115 cm polymer shaft with distal platinum alloy electrodes and proximal connector.
The catheters include steerable distal curves for remote manipulation and precise electrode positioning under fluoroscopic guidance. They are supplied as reprocessed devices that have undergone cleaning, inspection, testing, refurbishment, repackaging, and sterilization. The device is classified under product code NLH and has received FDA 510(k) clearance with decision code SESE.