510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K120533Substantially Equivalent

Bigboss Catheters Mantatay Catheter Mantaray Guidewires

Boston Scientific Corporation, Plymouth MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K120533 is the FDA 510(k) clearance record for BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES, a class II device, cleared for Bridgepoint Medical on under FDA product code PDU (Catheter For Crossing Total Occlusions). FDA's definition for product code PDU reads: "To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty...". FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K120533.

Clearance record

Decision date
Received
(90 days to decision)
Product code
PDU Catheter For Crossing Total Occlusions
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Bridgepoint Medical 13355 10th Ave. N Suite 110, Plymouth MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PDU

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