The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Venous Perfusion Cannula W/cuff Cat. No. 94015.
| Device ID | K860149 |
| 510k Number | K860149 |
| Device Name: | VENOUS PERFUSION CANNULA W/CUFF CAT. NO. 94015 |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Contact | Ronald Williams |
| Correspondent | Ronald Williams DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-15 |
| Decision Date | 1986-03-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994499206 | K860149 | 000 |
| 20613994625803 | K860149 | 000 |
| 20613994625827 | K860149 | 000 |
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