510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830016Substantially Equivalent

Vascutek Vascular Prothesis Vp1200k/50k

Pacesetter Systems, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830016 is the FDA 510(k) clearance record for VASCUTEK VASCULAR PROTHESIS VP1200K/50K, a class II device, cleared for Pacesetter Systems on under FDA product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter). FDA records list 96 510(k) clearances for Pacesetter Systems, from to . As of , FDA records show no recalls naming K830016.

Clearance record

Decision date
Received
(352 days to decision)
Product code
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Regulation
21 CFR 870.3450
Device class
Class II
Review panel
Cardiovascular
Applicant
Pacesetter Systems 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code DSY

Trailing 12 months
1 clearance under product code DSY in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260