510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K010831Substantially Equivalent

Aviator Peripheral Dilatation Catheter

Boston Scientific Corporation, Temecula CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K010831 is the FDA 510(k) clearance record for AVIATOR PERIPHERAL DILATATION CATHETER, a class II device, cleared for Guidant Corp. on under FDA product code DQY (Catheter, Percutaneous). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K010831.

Clearance record

Decision date
Received
(85 days to decision)
Product code
DQY Catheter, Percutaneous
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Guidant Corp. 26531 Ynez Rd., Temecula CA
510(k) summary
Summary
Third party review
No

Clearances, product code DQY

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