510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K953289Substantially Equivalent

Tetrafluoroethylene (Tfe) Polymer Pledget

Davis & Geck, Inc., Danbury CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953289 is the FDA 510(k) clearance record for TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGET, a class II device, cleared for Davis & Geck, Inc. on under FDA product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene). FDA records list 45 510(k) clearances for Davis & Geck, Inc., from to . As of , FDA records show no recalls naming K953289.

Clearance record

Decision date
Received
(38 days to decision)
Product code
DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Regulation
21 CFR 870.3470
Device class
Class II
Review panel
Cardiovascular
Applicant
Davis & Geck, Inc. One Casper St., Danbury CT
510(k) summary
Statement
Third party review
No

Clearances, product code DXZ

Trailing 12 months

FDA records hold no clearances under product code DXZ in the trailing twelve months.

FDA records show no clearances under product code DXZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DXZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260