The following data is part of a premarket notification filed by Coeur, Inc. with the FDA for Disposable High Pressure Injection Lines With And Without Rotating Adapters.
| Device ID | K071196 |
| 510k Number | K071196 |
| Device Name: | DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | COEUR, INC. 704 CADET COURT Lebanon, TN 37087 |
| Contact | Debra F Manning |
| Correspondent | Debra F Manning COEUR, INC. 704 CADET COURT Lebanon, TN 37087 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-30 |
| Decision Date | 2007-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884389880609 | K071196 | 000 |
| 10884389845080 | K071196 | 000 |
| 10884389845097 | K071196 | 000 |
| 10884389845103 | K071196 | 000 |
| 10884389845110 | K071196 | 000 |
| 10884389845127 | K071196 | 000 |
| 10884389845134 | K071196 | 000 |
| 10884389845202 | K071196 | 000 |
| 10884389845219 | K071196 | 000 |
| 10884389845226 | K071196 | 000 |
| 10884389845233 | K071196 | 000 |
| 10884389845240 | K071196 | 000 |
| 10884389845257 | K071196 | 000 |
| 10884389845264 | K071196 | 000 |
| 10884389833643 | K071196 | 000 |