510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K161208Substantially Equivalent

CROSSER CTO Recanalization Catheter

Bard Peripheral Vacular, Inc., Tempe AZ / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161208 is the FDA 510(k) clearance record for CROSSER CTO Recanalization Catheter, a class II device, cleared for Bard Peripheral Vacular, Inc. 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 one 510(k) clearance for Bard Peripheral Vacular, Inc. As of , FDA records show no recalls naming K161208.

Clearance record

Decision date
Received
(26 days to decision)
Product code
PDU Catheter For Crossing Total Occlusions
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Bard Peripheral Vacular, Inc. 1625 W. 3rd St., Tempe AZ
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