510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K993648Substantially Equivalent

Rotablator Rotational Angioplasty System with the Rotalink Exchangeable Catheter

Boston Scientific Corporation Northwest Technology, Redmond WA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K993648 is the FDA 510(k) clearance record for ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER, a class II device, cleared for Boston Scientific Corporation Northwest Technology on under FDA product code MCW (Catheter, Peripheral, Atherectomy). FDA records list 2 510(k) clearances for Boston Scientific Corporation Northwest Technology, from to . As of , FDA records show no recalls naming K993648.

Clearance record

Decision date
Received
(26 days to decision)
Product code
MCW Catheter, Peripheral, Atherectomy
Regulation
21 CFR 870.4875
Device class
Class II
Review panel
Cardiovascular
Applicant
Boston Scientific Corporation Northwest Technology 17425 NE Union Hill Rd., Redmond WA
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 October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MCW, 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