The following data is part of a premarket notification filed by Imperative Care Inc. with the FDA for Eagleray Long Sheath, 0.088 Id, 80cm, 90cm, 100cm And 110cm Lengths, Eagleray Access Catheter, 0.071 Id, 137cm Length, Eagleray Access Catheter, 0.055 Id, 137cm Length, Eagleray Access Catheter, 0.045 Id, 144cm Length, Eagleray Access Catheter, 0.035.
| Device ID | K180169 |
| 510k Number | K180169 |
| Device Name: | EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm And 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 |
| Classification | Catheter, Percutaneous |
| Applicant | Imperative Care Inc. 1221 Innsbruck Drive Sunnyvale, CA 94089 |
| Contact | Jake Wolenberg |
| Correspondent | Jake Wolenberg Imperative Care Inc. 1221 Innsbruck Drive Sunnyvale, CA 94089 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-22 |
| Decision Date | 2018-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812212030030 | K180169 | 000 |
| 00812212030023 | K180169 | 000 |
| 00812212030016 | K180169 | 000 |
| 00812212030009 | K180169 | 000 |
| 00812212030139 | K180169 | 000 |
| 00812212030122 | K180169 | 000 |
| 00812212030177 | K180169 | 000 |
| 00812212030160 | K180169 | 000 |