510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864146Substantially Equivalent

Deknatel Gwathmey Vascular Stapling Kit (Tenative)

Cardio Thoracic Systems, Cupertino CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864146 is the FDA 510(k) clearance record for DEKNATEL GWATHMEY VASCULAR STAPLING KIT (TENATIVE), a class II device, cleared for Cardio Thoracic Systems on under FDA product code GDW (Staple, Implantable). FDA records list 3 510(k) clearances for Cardio Thoracic Systems, from to . As of , FDA records show no recalls naming K864146.

Clearance record

Decision date
Received
(14 days to decision)
Product code
GDW Staple, Implantable
Regulation
21 CFR 878.4750
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Cardio Thoracic Systems 10600 N. Tantau Ave., Cupertino CA
Third party review
No

Clearances, product code GDW

Trailing 12 months
4 clearances under product code GDW 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 GDW, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20261
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260