26MM Diameter Hancock* Trocar Blade and Tip
FDA 510(k) K882479 · Medtronic Blood Systems, Inc.
510(k) numberK882479
Submission
- Device name
- 26MM Diameter Hancock* Trocar Blade and Tip
- Applicant
- Medtronic Blood Systems, Inc.
Anaheim, CA, US - Received
- June 16, 1988
- Decision date
- July 18, 1988
- 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
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| K022238 | Myocardial Lead Implant Tool, Model 10626DWS · Traditional | Medtronic Vascular | 10/09/2002SE |
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| 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 |
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| K893207 | Closed Chest Support CircuitDTZ · Traditional | 12/12/1989SE |
| K893678 | Duran Flexible Annuloplasty Ring & Obturator H601HKRH · Traditional | 11/27/1989SE |
| K891687 | Extracorporeal Circuit with Bio-Active SurfaceDTZ · Traditional | 05/31/1989SE |
| K891230 | Maxima* Hollow Fiber Oxygenator W/Filtered Reserv.DTZ · Traditional | 05/19/1989SE |
| K885154 | Intersept* Crystalloid Cardioplegia Deliv. SystemKRJ · Traditional | 02/22/1989SE |
| K884390 | Intersept* Crystalloid Cardioplegia FilterKRJ · Traditional | 12/21/1988SE |
| K884244 | Intersept* Prebypass FilterKRJ · Traditional | 12/05/1988SE |
| K883439 | Intersept*Crystalloid Cardioplegia Delivery SystemDTR · Traditional | 10/13/1988SE |
Questions and answers
When was 26MM Diameter Hancock* Trocar Blade and Tip cleared by the FDA?
26MM Diameter Hancock* Trocar Blade and Tip (K882479) received a 510(k) decision of Substantially Equivalent on July 18, 1988, 32 days after the submission was received.
What is the product code of K882479?
The FDA product code is DWS – Instruments, Surgical, Cardiovascular, a Class I (low risk) device regulated under 21 CFR 870.4500.