The following data is part of a premarket notification filed by Cardiac Pacemakers, Inc. with the FDA for Lead Stylet.
| Device ID | K905674 |
| 510k Number | K905674 |
| Device Name: | LEAD STYLET |
| Classification | Stylet, Catheter |
| Applicant | CARDIAC PACEMAKERS, INC. 4100 HAMLINE AVE., NORTH P.O. BOX 64079 St. Paul, MN 55112 -5798 |
| Contact | Stephan Norsted |
| Correspondent | Stephan Norsted CARDIAC PACEMAKERS, INC. 4100 HAMLINE AVE., NORTH P.O. BOX 64079 St. Paul, MN 55112 -5798 |
| Product Code | DRB |
| CFR Regulation Number | 870.1380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-18 |
| Decision Date | 1991-01-30 |