510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953647Substantially Equivalent

Ms Classique Balloon Catheter W/hydropass Coating

Meadox Medicals, Div. Boston Scientific Corp., Oakland NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953647 is the FDA 510(k) clearance record for MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING, a class II device, cleared for Meadox Medicals, Div. Boston Scientific Corp. on under FDA product code LIT (Catheter, Angioplasty, Peripheral, Transluminal). FDA records list 53 510(k) clearances for Meadox Medicals, Div. Boston Scientific Corp., from to . As of , FDA records show no recalls naming K953647.

Clearance record

Decision date
Received
(651 days to decision)
Product code
LIT Catheter, Angioplasty, Peripheral, Transluminal
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Meadox Medicals, Div. Boston Scientific Corp. 112 Bauer Dr., Oakland NJ
510(k) summary
Summary
Third party review
No

Clearances, product code LIT

Trailing 12 months
5 clearances under product code LIT in the twelve months to October 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LIT, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20262
October 20260