The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Pti Heart-lift(tm) Cardiac Support Sling (sterile).
| Device ID | K881717 |
| 510k Number | K881717 |
| Device Name: | PTI HEART-LIFT(TM) CARDIAC SUPPORT SLING (STERILE) |
| Classification | Instruments, Surgical, Cardiovascular |
| Applicant | BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
| Product Code | DWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-21 |
| Decision Date | 1988-07-05 |