Castroviejo Vascular Scissors
FDA 510(k) K792576 · Edward Weck, Inc.
510(k) numberK792576
Submission
- Device name
- Castroviejo Vascular Scissors
- Applicant
- Edward Weck, Inc.
Mchenry, IL, US - Received
- December 13, 1979
- Decision date
- December 19, 1979
- 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 |
| 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 |
|---|---|---|
| K915378 | Weck TrocarHET · Traditional | 06/29/1992SE |
| K914690 | LM15(TM), Catalog Number - 523821GCJ · Traditional | 03/23/1992SE |
| K911915 | Hemoclip IIFZP · Traditional | 01/09/1992SE |
| K914470 | Pneumo-Seal(Tm)GCJ · Traditional | 11/29/1991SE |
| K911272 | Endoscopic Needlholder Cat. Number 114705FHG · Traditional | 07/02/1991SE |
| K902108 | Hem-O-Lok(Tm)FZP · Traditional | 08/06/1990SE |
| K902232 | Weck Electrosurgical Generator #174200GEI · Traditional | 08/02/1990SE |
| K897045 | Bowie-Dick Test Card Catalog Number 008018JOJ · Traditional | 02/15/1990SE |
| K871110 | Coronary Artery Bypass Graft (Cabg) MarkerDSY · Traditional | 08/27/1987SE |
| K851251 | Auto/Manual Titanium Hemoclip Ligating Clip 527200FZP · Traditional | 07/02/1985SE |
Questions and answers
When was Castroviejo Vascular Scissors cleared by the FDA?
Castroviejo Vascular Scissors (K792576) received a 510(k) decision of Substantially Equivalent on December 19, 1979, 6 days after the submission was received.
What is the product code of K792576?
The FDA product code is DWS – Instruments, Surgical, Cardiovascular, a Class I (low risk) device regulated under 21 CFR 870.4500.