The following data is part of a premarket notification filed by Cook Pacemaker Corp. with the FDA for Locking Stylet 2.
| Device ID | K970690 |
| 510k Number | K970690 |
| Device Name: | LOCKING STYLET 2 |
| Classification | Wire, Guide, Catheter |
| Applicant | COOK PACEMAKER CORP. RT. 66, RIVER RD. P.O. BOX 529 Leechburg, PA 15656 |
| Contact | Neal E Feanot, Ph.d.;e.e. |
| Correspondent | Neal E Feanot, Ph.d.;e.e. COOK PACEMAKER CORP. RT. 66, RIVER RD. P.O. BOX 529 Leechburg, PA 15656 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-25 |
| Decision Date | 1997-05-20 |
| Summary: | summary |