The following data is part of a premarket notification filed by Pace Medical with the FDA for Lead Introducer Set, Various Models And Sizes.
| Device ID | K931662 |
| 510k Number | K931662 |
| Device Name: | LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES |
| Classification | Introducer, Catheter |
| Applicant | PACE MEDICAL 391 TOTTEN POND RD. Waltham, MA 02451 |
| Contact | Robert C Mace |
| Correspondent | Robert C Mace PACE MEDICAL 391 TOTTEN POND RD. Waltham, MA 02451 |
| Product Code | DYB |
| Subsequent Product Code | DQX |
| Subsequent Product Code | DRE |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-05 |
| Decision Date | 1993-08-31 |