510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K020879Substantially Equivalent

Ivs Clip Closure System, Model 1002 (Ivs Clip Applier); Ivs Intruducer Set, Model 1001

Integrated Vascular Systems, Inc., Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020879 is the FDA 510(k) clearance record for IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER); IVS INTRUDUCER SET, MODEL 1001, a class II device, cleared for Integrated Vascular Systems, Inc. on under FDA product code FZP (Clip, Implantable). FDA records list 3 510(k) clearances for Integrated Vascular Systems, Inc., from to . As of , FDA records show no recalls naming K020879.

Clearance record

Decision date
Received
(191 days to decision)
Product code
FZP Clip, Implantable
Regulation
21 CFR 878.4300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Integrated Vascular Systems, Inc. 743 N. Pastoria Ave., Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FZP

Trailing 12 months
5 clearances under product code FZP in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FZP, trailing twelve months
MonthClearances
November 20251
December 20252
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20261
October 20260