The following data is part of a premarket notification filed by Medsurg Industries, Inc. with the FDA for 8.5 Fr. Pescutaneous Sheath Introducer System.
| Device ID | K880777 |
| 510k Number | K880777 |
| Device Name: | 8.5 FR. PESCUTANEOUS SHEATH INTRODUCER SYSTEM |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
| Contact | Tom Bonner |
| Correspondent | Tom Bonner MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-26 |
| Decision Date | 1988-05-24 |