The following data is part of a premarket notification filed by Procedure Products, Inc. with the FDA for Custom Coronary Manifold Kits.
| Device ID | K853749 |
| 510k Number | K853749 |
| Device Name: | CUSTOM CORONARY MANIFOLD KITS |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | PROCEDURE PRODUCTS, INC. 1801 WEST 4TH PLAIN BLVD. Vancouver, WA 98660 |
| Contact | Kurt George |
| Correspondent | Kurt George PROCEDURE PRODUCTS, INC. 1801 WEST 4TH PLAIN BLVD. Vancouver, WA 98660 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-09 |
| Decision Date | 1986-01-13 |