The following data is part of a premarket notification filed by Geister Medizintechnik Gmbh with the FDA for Valvulotome, Retrograde : 03-7500- 03-7510, Antegrade 03-7520.
| Device ID | K022823 |
| 510k Number | K022823 |
| Device Name: | VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 |
| Classification | Valvulotome |
| Applicant | GEISTER MEDIZINTECHNIK GMBH 152B BRIDGE ST. Hot Springs, NC 28743 |
| Contact | Dagmar Maser |
| Correspondent | Dagmar Maser GEISTER MEDIZINTECHNIK GMBH 152B BRIDGE ST. Hot Springs, NC 28743 |
| Product Code | MGZ |
| CFR Regulation Number | 870.4885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-26 |
| Decision Date | 2004-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887482090299 | K022823 | 000 |
| 00887482090282 | K022823 | 000 |
| 00887482049969 | K022823 | 000 |
| 00887482049952 | K022823 | 000 |
| 00887482049945 | K022823 | 000 |
| 00887482049938 | K022823 | 000 |