510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221163Substantially Equivalent

Tunnel Crossing Catheter

Tractus Vascular, LLC, Eatontown NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221163 is the FDA 510(k) clearance record for Tunnel Crossing Catheter, a class II device, cleared for Tractus Vascular, LLC 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 3 510(k) clearances for Tractus Vascular, LLC, from to . As of , FDA records show no recalls naming K221163.

Clearance record

Decision date
Received
(272 days to decision)
Product code
PDU Catheter For Crossing Total Occlusions
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Tractus Vascular, LLC 20 Meridian Rd., Eatontown NJ
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 October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PDU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260