510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131060Substantially Equivalent

Clearguard Hd End Cap

Pursuit Vascular, Inc., Maple Grove MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131060 is the FDA 510(k) clearance record for CLEARGUARD HD END CAP, a class II device, cleared for Pursuit Vascular, Inc. on under FDA product code PEH (Hemodialysis Catheter Luer End Cap). FDA's definition for product code PEH reads: "For use in hemodialysis catheters to reduce hub infection". FDA records list 2 510(k) clearances for Pursuit Vascular, Inc., from to . As of , FDA records show no recalls naming K131060.

Clearance record

Decision date
Received
(244 days to decision)
Product code
PEH Hemodialysis Catheter Luer End Cap
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Pursuit Vascular, Inc. 6901 E. Fish Lake Rd., Suite 166, Maple Grove MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PEH

Trailing 12 months

FDA records hold no clearances under product code PEH in the trailing twelve months.

FDA records show no clearances under product code PEH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PEH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260