The following data is part of a premarket notification filed by Kyphon, Inc. with the FDA for Discyphor Catheter System, Model D01a; Discyphor Introducer Needle, Model D01b.
| Device ID | K063071 |
| 510k Number | K063071 |
| Device Name: | DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | KYPHON, INC. 1221 CROSSMAN AVE. Sunnyvale, CA 94089 |
| Contact | Cindy Domecus |
| Correspondent | Cindy Domecus KYPHON, INC. 1221 CROSSMAN AVE. Sunnyvale, CA 94089 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-06 |
| Decision Date | 2007-04-13 |
| Summary: | summary |