510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K030005Substantially Equivalent

Vanguard Reprocessed Diagnostic Electrophysiology Catheter Accessory Cables

Stryker Sustainability Solutions, Lakeland FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030005 is the FDA 510(k) clearance record for VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER ACCESSORY CABLES, a class II device, cleared for Vanguard Medical Concepts, Inc. on under FDA product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)). FDA records list 88 510(k) clearances for Stryker Sustainability Solutions, from to . As of , FDA records show no recalls naming K030005.

Clearance record

Decision date
Received
(75 days to decision)
Product code
DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Regulation
21 CFR 870.2900
Device class
Class II
Review panel
Cardiovascular
Applicant
Vanguard Medical Concepts, Inc. 5307 Great Oak Dr., Lakeland FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DSA

Trailing 12 months
2 clearances under product code DSA in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSA, trailing twelve months
MonthClearances
December 20251
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260