Rotary Vascular Knife
FDA 510(k) K822829 · Medco Products, Co., Inc.
510(k) numberK822829
Submission
- Device name
- Rotary Vascular Knife
- Applicant
- Medco Products, Co., Inc.
Walker, MI, US - Received
- September 21, 1982
- Decision date
- November 17, 1982
- 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 |
|---|---|---|
| K932466 | Medchem Surgical Delivery SystemGCJ · Traditional | 08/09/1993SE |
| K913172 | Endoscopic Delivery SystemGCJ · Traditional | 09/06/1991SE |
| K860099 | Medco-Sonic NQ-2000IMI · Traditional | 04/09/1986SE |
| K852015 | Jyrochair, Model Sk-HITI · Traditional | 07/19/1985SE |
| K851659 | Skull Mounted Stereotactic Surgical DeviceHAW · Traditional | 07/01/1985SE |
| K844580 | Medcolator Model HVXIPF · Traditional | 02/25/1985SE |
| K842712 | Medcolator Model GXIPF · Traditional | 09/19/1984SE |
Questions and answers
When was Rotary Vascular Knife cleared by the FDA?
Rotary Vascular Knife (K822829) received a 510(k) decision of Substantially Equivalent on November 17, 1982, 57 days after the submission was received.
What is the product code of K822829?
The FDA product code is DWS – Instruments, Surgical, Cardiovascular, a Class I (low risk) device regulated under 21 CFR 870.4500.