510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K982363Substantially Equivalent

Oasis Thrombectomy Catheter System

Boston Scientific Corporation, Natick, MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982363 is the FDA 510(k) clearance record for OASIS THROMBECTOMY CATHETER SYSTEM, a class II device, cleared for Boston Scientific Corp on under FDA product code MCW (Catheter, Peripheral, Atherectomy). FDA records list 1,110 510(k) clearances for Boston Scientific Corp, from to . As of , FDA records show no recalls naming K982363.

Clearance record

Decision date
Received
(232 days to decision)
Product code
MCW Catheter, Peripheral, Atherectomy
Regulation
21 CFR 870.4875
Device class
Class II
Review panel
Cardiovascular
Applicant
Boston Scientific Corp One Boston Scientific Pl., Natick, MA
510(k) summary
Summary
Third party review
No

Clearances, product code MCW

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