510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K913940Substantially Equivalent

Response(tm) Steerable Catheter

Daig Corp., Minnetonka MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913940 is the FDA 510(k) clearance record for RESPONSE(TM) STEERABLE CATHETER, a class II device, cleared for Daig Corp. on under FDA product code DRA (Catheter, Steerable). FDA records list 35 510(k) clearances for Daig Corp., from to . As of , FDA records show no recalls naming K913940.

Clearance record

Decision date
Received
(511 days to decision)
Product code
DRA Catheter, Steerable
Regulation
21 CFR 870.1280
Device class
Class II
Review panel
Cardiovascular
Applicant
Daig Corp. 14901 Deveau Pl., Minnetonka MN
510(k) summary
Statement
Third party review
No

Clearances, product code DRA

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