VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER ACCESSORY CABLES— 510(k) K030005
Substantially EquivalentVanguard Medical Concepts, Inc.
FDA 510(k) clearance K030005 for VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER ACCESSORY CABLES, Substantially Equivalent on 2003-03-18. Applicant: Vanguard Medical Concepts, Inc.. Device class: 2.
Clearance details
- Applicant
- Vanguard Medical Concepts, Inc.
- Product code
- Product code DSA
- Device class
- Class 2
- Regulation
- 21 CFR 870.2900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lakeland, FL, US
Recent devices under product code DSA
view allMore clearances from Vanguard Medical Concepts, Inc.
view all- K053051 — VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
- K051616 — VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
- K051180 — VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
- K051043 — VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
- K050763 — VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
Adverse events under product code DSA
product code DSA- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.