The following data is part of a premarket notification filed by Cardiac Pacemakers, Inc. with the FDA for Replacement Parts For Cpi 6888 Lead Tunneler.
| Device ID | K934727 |
| 510k Number | K934727 |
| Device Name: | REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER |
| Classification | Instruments, Surgical, Cardiovascular |
| Applicant | CARDIAC PACEMAKERS, INC. 4100 HAMLINE AVE., NORTH P.O. BOX 64079 St. Paul, MN 55112 -5798 |
| Contact | Michele C Purcell |
| Correspondent | Michele C Purcell CARDIAC PACEMAKERS, INC. 4100 HAMLINE AVE., NORTH P.O. BOX 64079 St. Paul, MN 55112 -5798 |
| Product Code | DWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-01 |
| Decision Date | 1994-01-10 |