The following data is part of a premarket notification filed by Aptus Endosystems, Inc. with the FDA for Aptus Heli-fx Guide - 22cm Deflectable Length; Aptus Heli-fx Guide - 28cm Deflectable Length; Aptus Heli-fx Applier With.
| Device ID | K140036 |
| 510k Number | K140036 |
| Device Name: | APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH |
| Classification | Endovascular Suturing System |
| Applicant | APTUS ENDOSYSTEMS, INC. 271 GIBRALTAR DRIVE Sunnyvale, CA 94089 |
| Contact | Burt Goodson |
| Correspondent | Burt Goodson APTUS ENDOSYSTEMS, INC. 271 GIBRALTAR DRIVE Sunnyvale, CA 94089 |
| Product Code | OTD |
| CFR Regulation Number | 870.3460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-07 |
| Decision Date | 2014-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169647695 | K140036 | 000 |
| 00643169647664 | K140036 | 000 |
| 00643169647640 | K140036 | 000 |
| 00643169647626 | K140036 | 000 |
| 00643169647602 | K140036 | 000 |
| 00643169647572 | K140036 | 000 |
| 00643169647565 | K140036 | 000 |