The following data is part of a premarket notification filed by Aptus Endosystems, Inc. with the FDA for Aptus 18fr Helifx Guide-22 Deflectable Length.
| Device ID | K121168 |
| 510k Number | K121168 |
| Device Name: | APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH |
| Classification | Endovascular Suturing System |
| Applicant | APTUS ENDOSYSTEMS, INC. 777 N. PASTORIA AVE. Sunnyvale, CA 94085 |
| Contact | Burt Goodson |
| Correspondent | Burt Goodson APTUS ENDOSYSTEMS, INC. 777 N. PASTORIA AVE. Sunnyvale, CA 94085 |
| Product Code | OTD |
| CFR Regulation Number | 870.3460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-17 |
| Decision Date | 2012-08-08 |
| Summary: | summary |