The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Mahurkar Dual Lumen Catheter.
| Device ID | K943349 |
| 510k Number | K943349 |
| Device Name: | MAHURKAR DUAL LUMEN CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Contact | Jerry Freundlich |
| Correspondent | Jerry Freundlich QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-12 |
| Decision Date | 1995-03-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30884521005314 | K943349 | 000 |
| 10884521057104 | K943349 | 000 |
| 10884521057098 | K943349 | 000 |
| 20884521005270 | K943349 | 000 |
| 20884521005263 | K943349 | 000 |
| 20884521005225 | K943349 | 000 |
| 20884521005195 | K943349 | 000 |
| 20884521005096 | K943349 | 000 |
| 20884521005072 | K943349 | 000 |
| 20884521004969 | K943349 | 000 |
| 10884521057111 | K943349 | 000 |
| 10884521057203 | K943349 | 000 |
| 10884521004870 | K943349 | 000 |
| 20884521005447 | K943349 | 000 |
| 20884521005423 | K943349 | 000 |
| 20884521005409 | K943349 | 000 |
| 20884521005461 | K943349 | 000 |
| 10884521057241 | K943349 | 000 |
| 10884521057234 | K943349 | 000 |
| 10884521057227 | K943349 | 000 |
| 10884521057210 | K943349 | 000 |
| 20884521004938 | K943349 | 000 |