Company ยท CR
Deknatel, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1997. Name variants (Inc, Corp, punctuation) are merged.
37510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CAC | Apparatus, Autotransfusion | 11 |
| KDQ | Bottle, Collection, Vacuum | 5 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 4 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 2 |
| JOL | Catheter And Tip, Suction | 2 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 1 |
| DWS | Instruments, Surgical, Cardiovascular | 1 |
| GAL | Suture, Absorbable, Natural | 1 |
| GAP | Suture, Nonabsorbable, Silk | 1 |
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | 1 |
| GBX | Catheter, Irrigation | 1 |
| GDW | Staple, Implantable | 1 |
| HIF | Insufflator, Laparoscopic | 1 |
| HRH | Trephine, Manual, Ophthalmic | 1 |
| ITG | Bandage, Cast | 1 |
| KGO | Surgeon'S Gloves | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 |
| LDF | Electrode, Pacemaker, Temporary | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 22, 1997 | K963850 | PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM Deknatel, Inc. | CAC |
| Jan 10, 1997 | K962683 | SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR Deknatel, Inc. | HIF |
| Dec 31, 1996 | K964070 | DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG Deknatel, Inc. | CAC |
| Nov 8, 1996 | K963098 | PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100) Deknatel, Inc. | CAC |
| Aug 28, 1996 | K962856 | PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR Deknatel, Inc. | KDQ |
| Jul 27, 1994 | K925243 | DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER Deknatel, Inc., CR | GBX |
| Jul 26, 1994 | K930740 | SURGICAL SUTURE, NONABSORABLE STAINLESS STEEL Deknatel, Inc., CR | GAQ |
| Jul 26, 1994 | K930739 | SUTURES POLYPROP., POLYETHELINE, NYLON & SILK Deknatel, Inc., CR | GAP |
| Jul 26, 1994 | K930738 | SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC Deknatel, Inc., CR | GAL |
| Jul 26, 1994 | K926338 | PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F Deknatel, Inc., CR | CAC |
| Oct 6, 1993 | K931106 | BIOSURGE(TM) SYNCHRONOUS AUTOTRANS PROCEDURE KIT Deknatel, Inc., CR | CAC |
| Jul 28, 1993 | K924337 | PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS Deknatel, Inc., CR | GCX |
| Apr 20, 1993 | K925046 | PLEUR-EVAC CARDIOTOMY RESERVOIR Deknatel, Inc., CR | DTN |
| Jul 2, 1991 | K911905 | DEKNATEL(R) MICROFLEX OPHTHAL POLY SUTURE,MODIFIED Deknatel, Inc., CR | GAW |
| Apr 3, 1991 | K910211 | ORTH-EVAC(TM) SUCTION HAND BULB MODEL NO. 01-150 Deknatel, Inc., CR | CAC |
| Feb 11, 1991 | K905768 | PLEUR-EVAC CHEST DRAINAGE SYSTEMS Deknatel, Inc., CR | KDQ |
| Dec 24, 1990 | K903643 | DEKNATEL MICROFLEX OPHTHALMIC POLYPROPYLENE SUTURE Deknatel, Inc., CR | GAW |
| Jul 3, 1990 | K900325 | ORTH-EVAC TM Deknatel, Inc., CR | CAC |
| Feb 8, 1990 | K896697 | PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAI Deknatel, Inc., CR | KDQ |
| Jun 21, 1989 | K892915 | PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION Deknatel, Inc., CR | KDQ |
| Apr 13, 1989 | K890432 | DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM) Deknatel, Inc., CR | DWS |
| Apr 10, 1989 | K890129 | PLEUR-EVAC(R) A-8020--INFANT CHEST DRAINAGE SYSTEM Deknatel, Inc., CR | GCX |
| Apr 4, 1989 | K890431 | PLEUR-EVAC(R) A-8000--ADULT/PEDIATRIC CHEST DRAIN Deknatel, Inc., CR | GCX |
| Jan 24, 1989 | K884844 | PLEUR-EVAC(R) A-7002--ADULT/PEDIATRIC DRAINAGE Deknatel, Inc., CR | CAC |
| Oct 13, 1988 | K883082 | PLEUR-EVAC(R)-A-7020-INFANT CHEST DRAIN SYSTEM Deknatel, Inc. | CAC |
| Aug 16, 1988 | K882223 | PLEUR-EVAC-A-7000--ADULT/PEDI CHEST DRAINAGE SYST Deknatel, Inc. | KDQ |
| Jun 17, 1988 | K881252 | PLEUR-EVAC(R) A6000 ADULT/PEDIATRIC CHEST DRAINAGE Deknatel, Inc. | GCX |
| Mar 21, 1988 | K880162 | PLEUR-EVAC--A-5002 CHEST DRAINAGE SYSTEM W/AUTO Deknatel, Inc. | CAC |
| Jan 6, 1988 | K873748 | RICA(TM)-RING INTEST. COMPRESS. STAPLE ANASTOM KIT Deknatel, Inc. | GDW |
| Nov 3, 1987 | K873728 | DEKNATEL TEMPORARY CARDIAC PACING WIRE Deknatel, Inc. | LDF |
| Nov 2, 1987 | K873525 | DEKNATEL TROCAR CATHETER Deknatel, Inc. | JOL |
| Nov 2, 1987 | K873517 | DEKNATEL THORACIC CATHETER Deknatel, Inc. | JOL |
| Aug 19, 1986 | K862115 | DEKNA BAND KIT Deknatel, Inc. | ITG |
| Aug 11, 1986 | K862524 | DEKNATEL (R) TREPHINE Deknatel, Inc. | HRH |
| Jan 8, 1986 | K855121 | COLOSHIELD KIT Deknatel, Inc. | KNT |
| Nov 19, 1985 | K854301 | PLEUR-EVAC II AUTOTRANSFUSION SYSTEM Deknatel, Inc. | CAC |
| Aug 9, 1976 | K760248 | GLOVES, APARTICULATE SURGICAL Deknatel, Inc. | KGO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||