Deknatel, Inc.
Fall River, MA, US
Deknatel, Inc. appears in FDA device records in Fall River, MA. FDA records list 37 510(k) clearances between and , 40 PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 37
- PMA records
- 40
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 37 510(k) clearances for Deknatel, Inc. between 1976 and 1997. The busiest year on record is 1988, with 5. The most recent is 1997, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1985 | 1 |
| 1986 | 3 |
| 1987 | 3 |
| 1988 | 5 |
| 1989 | 5 |
| 1990 | 3 |
| 1991 | 3 |
| 1993 | 3 |
| 1994 | 5 |
| 1996 | 3 |
| 1997 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K963850 | PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM | CAC | Substantially Equivalent | |
| K962683 | SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR | HIF | Substantially Equivalent | |
| K964070 | DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG | CAC | Substantially Equivalent | |
| K963098 | PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100) | CAC | Substantially Equivalent | |
| K962856 | PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR | KDQ | Substantially Equivalent | |
| K925243 | DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER | GBX | Substantially Equivalent | |
| K930740 | SURGICAL SUTURE, NONABSORABLE STAINLESS STEEL | GAQ | Substantially Equivalent | |
| K930739 | SUTURES POLYPROP., POLYETHELINE, NYLON & SILK | GAP | Substantially Equivalent | |
| K930738 | SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC | GAL | Substantially Equivalent | |
| K926338 | PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F | CAC | Substantially Equivalent | |
| K931106 | BIOSURGE(TM) SYNCHRONOUS AUTOTRANS PROCEDURE KIT | CAC | Substantially Equivalent | |
| K924337 | PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS | GCX | Substantially Equivalent | |
| K925046 | PLEUR-EVAC CARDIOTOMY RESERVOIR | DTN | Substantially Equivalent | |
| K911905 | DEKNATEL(R) MICROFLEX OPHTHAL POLY SUTURE,MODIFIED | GAW | Substantially Equivalent | |
| K910211 | ORTH-EVAC(TM) SUCTION HAND BULB MODEL NO. 01-150 | CAC | Substantially Equivalent | |
| K905768 | PLEUR-EVAC CHEST DRAINAGE SYSTEMS | KDQ | Substantially Equivalent | |
| K903643 | DEKNATEL MICROFLEX OPHTHALMIC POLYPROPYLENE SUTURE | GAW | Substantially Equivalent | |
| K900325 | ORTH-EVAC TM | CAC | Substantially Equivalent | |
| K896697 | PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAI | KDQ | Substantially Equivalent | |
| K892915 | PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION | KDQ | Substantially Equivalent | |
| K890432 | DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM) | DWS | Substantially Equivalent | |
| K890129 | PLEUR-EVAC(R) A-8020--INFANT CHEST DRAINAGE SYSTEM | GCX | Substantially Equivalent | |
| K890431 | PLEUR-EVAC(R) A-8000--ADULT/PEDIATRIC CHEST DRAIN | GCX | Substantially Equivalent | |
| K884844 | PLEUR-EVAC(R) A-7002--ADULT/PEDIATRIC DRAINAGE | CAC | Substantially Equivalent | |
| K883082 | PLEUR-EVAC(R)-A-7020-INFANT CHEST DRAIN SYSTEM | CAC | Substantially Equivalent | |
| K882223 | PLEUR-EVAC-A-7000--ADULT/PEDI CHEST DRAINAGE SYST | KDQ | Substantially Equivalent | |
| K881252 | PLEUR-EVAC(R) A6000 ADULT/PEDIATRIC CHEST DRAINAGE | GCX | Substantially Equivalent | |
| K880162 | PLEUR-EVAC--A-5002 CHEST DRAINAGE SYSTEM W/AUTO | CAC | Substantially Equivalent | |
| K873748 | RICA(TM)-RING INTEST. COMPRESS. STAPLE ANASTOM KIT | GDW | Substantially Equivalent | |
| K873728 | DEKNATEL TEMPORARY CARDIAC PACING WIRE | LDF | Substantially Equivalent | |
| K873525 | DEKNATEL TROCAR CATHETER | JOL | Substantially Equivalent | |
| K873517 | DEKNATEL THORACIC CATHETER | JOL | Substantially Equivalent | |
| K862115 | DEKNA BAND KIT | ITG | Substantially Equivalent | |
| K862524 | DEKNATEL (R) TREPHINE | HRH | Substantially Equivalent | |
| K855121 | COLOSHIELD KIT | KNT | Substantially Equivalent | |
| K854301 | PLEUR-EVAC II AUTOTRANSFUSION SYSTEM | CAC | Substantially Equivalent | |
| K760248 | GLOVES, APARTICULATE SURGICAL | KGO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CACApparatus, Autotransfusion
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
- ITGBandage, Cast
- KDQBottle, Collection, Vacuum
- JOLCatheter And Tip, Suction
- GBXCatheter, Irrigation
- LDFElectrode, Pacemaker, Temporary
- DWSInstruments, Surgical, Cardiovascular
- HIFInsufflator, Laparoscopic
- DTNReservoir, Blood, Cardiopulmonary Bypass
- GDWStaple, Implantable
- KGOSurgeon'S Gloves
- GALSuture, Absorbable, Natural
- GAPSuture, Nonabsorbable, Silk
- GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- GARSuture, Nonabsorbable, Synthetic, Polyamide
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- GAWSuture, Nonabsorbable, Synthetic, Polypropylene
- HRHTrephine, Manual, Ophthalmic
- KNTTubes, Gastrointestinal (And Accessories)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Deknatel, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Deknatel, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain