Deknatel High Precision Vascular Punch(Tm)
FDA 510(k) K890432 · Deknatel, Inc.
510(k) numberK890432
Submission
- Device name
- Deknatel High Precision Vascular Punch(Tm)
- Applicant
- Deknatel, Inc.
San Jose-Heredia, CR - Received
- January 27, 1989
- Decision date
- April 13, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DWS – Instruments, Surgical, Cardiovascular
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.4500
- Specialty
- Cardiovascular
Other 510(k)s with product code DWS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K022238 | Myocardial Lead Implant Tool, Model 10626DWS · Traditional | Medtronic Vascular | 10/09/2002SE |
| K964445 | Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006)DWS · Traditional | Dlp, Inc. | 01/30/1997SE |
| K962771 | Burke Congenital Thoracoscopy InstrumentsDWS · Traditional | Pilling Weck, Inc. | 11/19/1996SE |
| K955689 | RNS Sterile, Disposable Digital Angiographic TrayDWS · Traditional | Contour Fabricators of Florida, Inc. | 05/15/1996SE |
| K960139 | G.E. Sterile Angiographic TrayDWS · Traditional | GE Medical Systems | 04/19/1996SESK |
| K960144 | G.E. Sterile CT Biopsy TrayDWS · Traditional | GE Medical Systems | 04/15/1996SESK |
| K960143 | G.E. Sterile Digital Angiographic TrayDWS · Traditional | GE Medical Systems | 04/09/1996SESK |
| K934727 | Replacement Parts for Cpi 6888 Lead TunnelerDWS · Traditional | Cardiac Pacemakers, Inc. | 01/10/1994SE |
| K900379 | Hycult Diamond Coronary Bypass KnifeDWS · Traditional | St. Jude Medical, Inc. | 03/19/1990SE |
| K896307 | Insulation PadDWS · Traditional | Bio-Vascular, Inc. | 01/19/1990SE |
More from Bio-Vascular, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K963850 | Pleur-Evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion SystemCAC · Traditional | 04/22/1997SE |
| K962683 | Snowden-Pencer Computerized High Flow InsufflatorHIF · Traditional | 01/10/1997SE |
| K964070 | Deknatel DSP Pleur-Evac Autotransfusion Blood Recovery BagCAC · Traditional | 12/31/1996SE |
| K963098 | Pleur-Evac Shara Plus Model S-2150/CONTINUOUS Reinfusion Autotransfusion SYSTEM(S-100)CAC · Traditional | 11/08/1996SE |
| K962856 | Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model S-1100, S-1200, 2-2100…KDQ · Traditional | 08/28/1996SE |
| K925243 | Deknatel(Tm) Pleur-Evac(R) Thoracic CatheterGBX · Traditional | 07/27/1994SE |
| K930740 | Surgical Suture, Nonabsorable Stainless SteelGAQ · Traditional | 07/26/1994SE |
| K930739 | Sutures Polyprop., Polyetheline, Nylon & SilkGAP · Traditional | 07/26/1994SE |
| K930738 | Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcGAL · Traditional | 07/26/1994SE |
| K926338 | Pleur-Evac Cardiotomy Reservoir # CR-9400 & 9400FCAC · Traditional | 07/26/1994SE |
Questions and answers
When was Deknatel High Precision Vascular Punch(Tm) cleared by the FDA?
Deknatel High Precision Vascular Punch(Tm) (K890432) received a 510(k) decision of Substantially Equivalent on April 13, 1989, 76 days after the submission was received.
What is the product code of K890432?
The FDA product code is DWS – Instruments, Surgical, Cardiovascular, a Class I (low risk) device regulated under 21 CFR 870.4500.