The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Pressure Monitoring Injection Lines.
| Device ID | K781558 |
| 510k Number | K781558 |
| Device Name: | PRESSURE MONITORING INJECTION LINES |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | COBE LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-09-11 |
| Decision Date | 1978-10-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886333208948 | K781558 | 000 |
| 20886333201062 | K781558 | 000 |
| 20886333201017 | K781558 | 000 |
| 20886333201000 | K781558 | 000 |
| 20886333200973 | K781558 | 000 |
| 20886333200966 | K781558 | 000 |
| 20886333200942 | K781558 | 000 |
| 20886333200928 | K781558 | 000 |
| 20886333200911 | K781558 | 000 |
| 20886333200904 | K781558 | 000 |
| 20886333200881 | K781558 | 000 |
| 20886333200874 | K781558 | 000 |
| 20886333200850 | K781558 | 000 |
| 20886333200843 | K781558 | 000 |
| 20886333200829 | K781558 | 000 |
| 20886333200812 | K781558 | 000 |
| 20886333200799 | K781558 | 000 |
| 20886333201079 | K781558 | 000 |
| 20886333201086 | K781558 | 000 |
| 20886333201291 | K781558 | 000 |
| 20886333201284 | K781558 | 000 |
| 20886333201277 | K781558 | 000 |
| 20886333201260 | K781558 | 000 |
| 20886333201253 | K781558 | 000 |
| 20886333201246 | K781558 | 000 |
| 20886333201222 | K781558 | 000 |
| 20886333201215 | K781558 | 000 |
| 20886333201208 | K781558 | 000 |
| 20886333201185 | K781558 | 000 |
| 20886333201161 | K781558 | 000 |
| 20886333201154 | K781558 | 000 |
| 20886333201123 | K781558 | 000 |
| 20886333201116 | K781558 | 000 |
| 20886333201109 | K781558 | 000 |
| 20886333201093 | K781558 | 000 |
| 20886333200782 | K781558 | 000 |