The following data is part of a premarket notification filed by Medical Parameters, Inc. with the FDA for Walrus: Double Balloon Shunting Catheter.
| Device ID | K862190 |
| 510k Number | K862190 |
| Device Name: | WALRUS: DOUBLE BALLOON SHUNTING CATHETER |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MEDICAL PARAMETERS, INC. 20 CABOT RD. Woburn, MA 01801 |
| Contact | Walter Maceachern |
| Correspondent | Walter Maceachern MEDICAL PARAMETERS, INC. 20 CABOT RD. Woburn, MA 01801 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-09 |
| Decision Date | 1986-11-03 |