The following data is part of a premarket notification filed by Procedure Products, Inc. with the FDA for Angio Waste Fluids Dump Bag.
| Device ID | K874037 |
| 510k Number | K874037 |
| Device Name: | ANGIO WASTE FLUIDS DUMP BAG |
| Classification | Catheter, Intravascular, Diagnostic |
| 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 | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-05 |
| Decision Date | 1988-01-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B1604822102 | K874037 | 000 |
| B16045592 | K874037 | 000 |