510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K941058Substantially Equivalent

Procath Pacing Threshold Cable

Professional Catheter Corp., Berlin NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941058 is the FDA 510(k) clearance record for PROCATH PACING THRESHOLD CABLE, a class II device, cleared for Professional Catheter Corp. on under FDA product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)). FDA records list one 510(k) clearance for Professional Catheter Corp. As of , FDA records show no recalls naming K941058.

Clearance record

Decision date
Received
(125 days to decision)
Product code
DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Regulation
21 CFR 870.2900
Device class
Class II
Review panel
Cardiovascular
Applicant
Professional Catheter Corp. 334 D-6 Cooper Rd., Berlin NJ
510(k) summary
Statement
Third party review
No

Clearances, product code DSA

Trailing 12 months
2 clearances under product code DSA in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSA, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260