Atlas FDA

DEKNATEL THORACIC CATHETER

FDA 510(k) clearance K852041 · decided 1985-06-17

Clearance details

K-number
K852041
Device name
DEKNATEL THORACIC CATHETER
Applicant
Pfizer, Inc.
Decision
Substantially Equivalent
Date received
1985-05-09
Decision date
1985-06-17
Days to decision
39 days
Clearance type
Traditional
Product code
JOL
Device class
2
Regulation number
880.6740
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Ny, NY, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014 (K051370)Baxter Healthcare Corp2005-08-12
PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION (K000266)Primary Care Solutions, Inc.2001-07-12
PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION (K000265)Primary Care Solutions, Inc.2001-07-12
WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION (K003402)Welcon, Inc.2001-05-01
STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP (K994321)Automatic Liquid Packaging, Inc.2000-10-25
HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE (K974759)Hydrox Laboratories1998-03-09
HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE (K974758)Hydrox Laboratories1998-03-09
STERILE SALINE FOR CATHETER CARE (K974397)Baxter Healthcare Corp1998-02-10
STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION (K973734)Welcon, Inc.1998-02-05
GERM TRAPPER SUCTION TUBE HOLDER (K972372)Rzv Medical Specialties, Inc.1997-12-11
CPR SUCTION CATHETER KIT (K960216)Custom Pack Reliability1996-04-15
STERILE ISOTONIC SALINE & STERILE WATER (K954442)Medcare Custom Packaging, Inc.1995-12-21

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
GELFOAM (absorbable gelatin gel, powder from abs. gel, sponge USP), GELFOAM (compressed absorbable gelatin sponge, USP), (N18286/S041)Pfizer, Inc.2023-05-16
(Gelfoam (absorbable gelatin) Sterile Sponge) (N18286/S040)Pfizer, Inc.2022-06-24
Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S039)Pfizer, Inc.2021-07-08
Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S038)Pfizer, Inc.2021-05-07
Gelfoam Sterile Sponge (N18286/S037)Pfizer, Inc.2021-02-24
Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S036)Pfizer, Inc.2020-12-10
Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S035)Pfizer, Inc.2020-03-19
Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S034)Pfizer, Inc.2020-02-27