510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801031Substantially Equivalent

Blade Septostomy Catheter

Cook, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801031 is the FDA 510(k) clearance record for BLADE SEPTOSTOMY CATHETER, a class II device, cleared for Cook, Inc. on under FDA product code DXF (Catheter, Septostomy). FDA records list 2 510(k) clearances for Cook, Inc., from to . As of , FDA records show no recalls naming K801031.

Clearance record

Decision date
Received
(88 days to decision)
Product code
DXF Catheter, Septostomy
Regulation
21 CFR 870.5175
Device class
Class II
Review panel
Cardiovascular
Applicant
Cook, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code DXF

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