Company ยท US
Puritas Health Care, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 1994. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FPA | Set, Administration, Intravascular | 6 |
| BSY | Catheters, Suction, Tracheobronchial | 3 |
| BRZ | Set, Blood Transfusion | 2 |
| MDA | Elastomer, Silicone, For Scar Management | 2 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 1 |
| CAT | Cannula, Nasal, Oxygen | 1 |
| DSS | Clip, Vascular | 1 |
| DXC | Clamp, Vascular | 1 |
| EXR | Urinometer, Mechanical | 1 |
| FMG | Stopcock, I.V. Set | 1 |
| FPB | Filter, Infusion Line | 1 |
| GBX | Catheter, Irrigation | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 1 |
| LHI | Set, I.V. Fluid Transfer | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 28, 1994 | K942339 | SKIN NEUVEAU SCAR TREATMENT Puritas Health Care, Inc. | MDA |
| Aug 11, 1994 | K941197 | SILK*SKIN SCAR TREATMENT Puritas Health Care, Inc. | MDA |
| May 10, 1994 | K935600 | TRACHEAL SUCTION CATHETER Puritas Health Care, Inc. | BSY |
| May 5, 1994 | K935531 | OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP Puritas Health Care, Inc. | GBX |
| Apr 21, 1994 | K940074 | Y-TYPE BLOOD ADMINISTRATION SET Puritas Health Care, Inc. | BRZ |
| Apr 15, 1994 | K940055 | MULTISET Puritas Health Care, Inc. | BRZ |
| Apr 15, 1994 | K940054 | MEASURED VOLUME SOLUTION ADMINISTRATION SET Puritas Health Care, Inc. | FPA |
| Apr 11, 1994 | K935583 | SUCTION SET, TRACHAEL Puritas Health Care, Inc. | BSY |
| Apr 4, 1994 | K940070 | STOPCOCK INTRAVENOUS THERAPY Puritas Health Care, Inc. | FMG |
| Apr 4, 1994 | K940056 | WINGED INFUSION SET A-PORT VASCULAR ACCESS SYSTEM Puritas Health Care, Inc. | FPA |
| Apr 4, 1994 | K935532 | TRANSFER SET Puritas Health Care, Inc. | LHI |
| Mar 28, 1994 | K940293 | 1.2 MICRON FINAL FILTER WITH EXTENSION TUBE Puritas Health Care, Inc. | FPB |
| Mar 28, 1994 | K940053 | INFUSION ADMINISTRATION SET Puritas Health Care, Inc. | FPA |
| Mar 23, 1994 | K940073 | EXTENSION TUBE, EXTENSION TUBE LENGTH 20, & 30 Puritas Health Care, Inc. | FPA |
| Mar 23, 1994 | K940072 | I.V. SET (20 DROPS/ML) Puritas Health Care, Inc. | FPA |
| Mar 7, 1994 | K935557 | URINARY DRAINAGE BAG Puritas Health Care, Inc. | KNX |
| Feb 3, 1994 | K935533 | NASAL CANNULA Puritas Health Care, Inc. | CAT |
| Jan 21, 1994 | K935601 | 0.22 MICRON FINAL FILTER WITH EXTENSION TUBE Puritas Health Care, Inc. | FPA |
| Jan 14, 1994 | K935582 | TUBE, INHALER OXYGEN Puritas Health Care, Inc. | BZO |
| Jan 14, 1994 | K935553 | MULLY SUCTION STRAIGHT WITH FINGERTIP/WITH FUNNEL/WITH VACUTIP Puritas Health Care, Inc. | BSY |
| Dec 17, 1993 | K935578 | URINE METER Puritas Health Care, Inc. | EXR |
| Jun 2, 1992 | K920501 | SILCLAMPS DEGANIA SILICONE Puritas Health Care, Inc. | DXC |
| Apr 20, 1992 | K920104 | IDENTI LOOPS DEGANIA SILICONE Puritas Health Care, Inc. | DSS |
| Jul 23, 1991 | K912542 | PURITAS 100% COTTON ABSORB OPER ROOM SURG TOWELS Puritas Health Care, Inc. | KKX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||