Medical Device Manufacturer · US , Brookfield , CT

Puritas Health Care, Inc.

24 submissions · 22 cleared · Since 1991
24
Total
22
Cleared
0
Denied

Puritas Health Care, Inc. — FDA 510(k) Submissions

Puritas Health Care, Inc. has submitted 24 FDA 510(k) premarket notifications since 1991, of which 22 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Set, Administration, Intravascular, Catheters, Suction, Tracheobronchial, Set, Blood Transfusion, Elastomer, Silicone, For Scar Management, Cannula, Nasal, Oxygen . Use the specialty filter in the sidebar to narrow results.

24 devices
1–12 of 24
SKIN NEUVEAU SCAR TREATMENT
K942339 · MDA Elastomer, Silicone, For... · General & Plastic Surgery
Nov 1994 196d
SILK*SKIN SCAR TREATMENT
K941197 · MDA Elastomer, Silicone, For... · General & Plastic Surgery
Aug 1994 150d
TRACHEAL SUCTION CATHETER
K935600 · BSY Catheters, Suction,... · Anesthesiology
May 1994 172d
OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP
K935531 · GBX Catheter, Irrigation · General & Plastic Surgery
May 1994 170d
Y-TYPE BLOOD ADMINISTRATION SET
K940074 · BRZ Set, Blood Transfusion · General Hospital
Apr 1994 105d
MEASURED VOLUME SOLUTION ADMINISTRATION SET
K940054 · FPA Set, Administration,... · General Hospital
Apr 1994 100d
MULTISET
K940055 · BRZ Set, Blood Transfusion · General Hospital
Apr 1994 100d
SUCTION SET, TRACHAEL
K935583 · BSY Catheters, Suction,... · Anesthesiology
Apr 1994 144d
TRANSFER SET
K935532 · LHI Set, I.v. Fluid Transfer · General Hospital
Apr 1994 139d
WINGED INFUSION SET A-PORT VASCULAR ACCESS SYSTEM
K940056 · FPA Set, Administration,... · General Hospital
Apr 1994 89d
STOPCOCK INTRAVENOUS THERAPY
K940070 · FMG Stopcock, I.v. Set · General Hospital
Apr 1994 88d
INFUSION ADMINISTRATION SET
K940053 · FPA Set, Administration,... · General Hospital
Mar 1994 82d
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