Medsurg Custom Cardiovascular Procedure Tray
FDA 510(k) K864461 · Medsurg Industries, Inc.
510(k) numberK864461
Submission
- Device name
- Medsurg Custom Cardiovascular Procedure Tray
- Applicant
- Medsurg Industries, Inc.
Herndon, VA, US - Received
- November 12, 1986
- Decision date
- November 24, 1986
- 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 |
|---|---|---|
| K920780 | Medsurg Insertion TrayLFJ · Traditional | 08/19/1994SEKD |
| K940175 | Medsurg Sterile O.R. TowelsKKX · Traditional | 05/26/1994SE |
| K934731 | Medsurg Sterile Imaging ProductsFMP · Traditional | 03/28/1994SE |
| K925558 | InfiltubeHIF · Traditional | 03/04/1994SE |
| K934971 | Sterile Laparotomy SpongesGDY · Traditional | 02/07/1994SE |
| K920421 | Medsurg Marshmallow TrayGAT · Traditional | 12/13/1993SESK |
| K920838 | Medsurg Circumcision TrayHFK · Traditional | 10/15/1993SE |
| K931932 | Dressing Change Tray-ModifiedMCY · Traditional | 08/27/1993SEKD |
| K914037 | Medsurg O.R. Procedure TrayLRO · Traditional | 06/22/1993SEKD |
| K914036 | Medsurg Laparoscopy TrayLRO · Traditional | 03/18/1992SE |
Questions and answers
When was Medsurg Custom Cardiovascular Procedure Tray cleared by the FDA?
Medsurg Custom Cardiovascular Procedure Tray (K864461) received a 510(k) decision of Substantially Equivalent on November 24, 1986, 12 days after the submission was received.
What is the product code of K864461?
The FDA product code is DWS – Instruments, Surgical, Cardiovascular, a Class I (low risk) device regulated under 21 CFR 870.4500.