510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991531Substantially Equivalent

Cordis Webster Diagnostic Deflectable Tip Catheter, Model D-1078

Cordis Webster, Inc., Baldwin Park CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991531 is the FDA 510(k) clearance record for CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078, a class II device, cleared for Cordis Webster, Inc. on under FDA product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording). FDA records list 10 510(k) clearances for Cordis Webster, Inc., from to . As of , FDA records show no recalls naming K991531.

Clearance record

Decision date
Received
(154 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
Cordis Webster, Inc. 4750 Littlejohn St., Baldwin Park 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