The following data is part of a premarket notification filed by Procedure Products, Inc. with the FDA for Connecting Set.
| Device ID | K914128 |
| 510k Number | K914128 |
| Device Name: | CONNECTING SET |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | PROCEDURE PRODUCTS, INC. 1801 WEST 4TH PLAIN BLVD. Vancouver, WA 98660 |
| Contact | Robert B Everett |
| Correspondent | Robert B Everett 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 | 1991-09-13 |
| Decision Date | 1991-11-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B160P24R1871 | K914128 | 000 |
| B160B36F711 | K914128 | 000 |
| B160B48F0711 | K914128 | 000 |
| B160B72F712 | K914128 | 000 |
| B160B72R0722 | K914128 | 000 |
| B160MF061 | K914128 | 000 |
| B160MF121 | K914128 | 000 |
| B160MF12LB1 | K914128 | 000 |
| B160MF241 | K914128 | 000 |
| B160MF481 | K914128 | 000 |
| B160MM361 | K914128 | 000 |
| B160MM481 | K914128 | 000 |
| B160MM721 | K914128 | 000 |
| B160P12R1872 | K914128 | 000 |
| B160B10R0721 | K914128 | 000 |