510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K083139Substantially Equivalent

Vipersphere Pta Balloon Catheter

Cardiovascular Systems Incorporated, Saint Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083139 is the FDA 510(k) clearance record for VIPERSPHERE PTA BALLOON CATHETER, a class II device, cleared for Cardiovascular Systems, Inc. on under FDA product code DQY (Catheter, Percutaneous). FDA records list 28 510(k) clearances for CARDIOVASCULAR SYSTEMS INCORPORATED, from to . As of , FDA records show no recalls naming K083139.

Clearance record

Decision date
Received
(33 days to decision)
Product code
DQY Catheter, Percutaneous
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Cardiovascular Systems, Inc. 651 Campus Dr., Saint Paul MN
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code DQY

Trailing 12 months
13 clearances under product code DQY in the twelve months to October 2026, July 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQY, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20260
March 20261
April 20262
May 20260
June 20262
July 20263
August 20262
September 20261
October 20260