The following data is part of a premarket notification filed by Medsurg Industries, Inc. with the FDA for Medsurg Custom Cardiovascular Procedure Tray.
| Device ID | K864461 |
| 510k Number | K864461 |
| Device Name: | MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE TRAY |
| Classification | Instruments, Surgical, Cardiovascular |
| Applicant | MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
| Contact | Donna Collier |
| Correspondent | Donna Collier MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
| Product Code | DWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-12 |
| Decision Date | 1986-11-24 |