510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970853Substantially Equivalent

Pathfinder 3Mm Mapping Microcatheter (01-082001)

Cardima, Inc., Fremont CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970853 is the FDA 510(k) clearance record for PATHFINDER 3MM MAPPING MICROCATHETER (01-082001), a class II device, cleared for Cardima, Inc. on under FDA product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording). FDA records list 12 510(k) clearances for Cardima, Inc., from to . As of , FDA records show no recalls naming K970853.

Clearance record

Decision date
Received
(242 days to decision)
Product code
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Regulation
21 CFR 870.1220
Device class
Class II
Review panel
Cardiovascular
Applicant
Cardima, Inc. 47266 Benicia St., Fremont CA
510(k) summary
Summary
Third party review
No

Clearances, product code DRF

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