MC-4000 Surgical Instruments Cardiovascular
FDA 510(k) K851152 · Cryomedics, Inc.
510(k) numberK851152
Submission
- Device name
- MC-4000 Surgical Instruments Cardiovascular
- Applicant
- Cryomedics, Inc.
Bridgeport, CT, US - Received
- March 21, 1985
- Decision date
- June 24, 1985
- 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 |
|---|---|---|
| K844431 | Yn CO2 Laser System 30WHHR · Traditional | 02/25/1985SE |
| K842888 | Dual Channel TENS, Pulsar Remote ContrlGZJ · Traditional | 01/14/1985SE |
| K842959 | MC-4000 Console & ProbesGEH · Traditional | 12/07/1984SE |
| K842704 | MT-700 MT-750 FT-350GEH · Traditional | 08/01/1984SE |
| K801730 | Krymed System 4001 Tilt ScopeHEX · Traditional | 08/13/1980SE |
| K800335 | Krymed Liquid Nitrogen CryojetGEH · Traditional | 04/04/1980SE |
Questions and answers
When was MC-4000 Surgical Instruments Cardiovascular cleared by the FDA?
MC-4000 Surgical Instruments Cardiovascular (K851152) received a 510(k) decision of Substantially Equivalent on June 24, 1985, 95 days after the submission was received.
What is the product code of K851152?
The FDA product code is DWS – Instruments, Surgical, Cardiovascular, a Class I (low risk) device regulated under 21 CFR 870.4500.