The following data is part of a premarket notification filed by Spectranetics Corp. with the FDA for Spectranetics Visisheath Dilator Sheath.
| Device ID | K092378 |
| 510k Number | K092378 |
| Device Name: | SPECTRANETICS VISISHEATH DILATOR SHEATH |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | SPECTRANETICS CORP. 96 TALAMINE CT. Colorado Springs, CO 80907 -5159 |
| Contact | Cheryl Hastings |
| Correspondent | Cheryl Hastings SPECTRANETICS CORP. 96 TALAMINE CT. Colorado Springs, CO 80907 -5159 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-05 |
| Decision Date | 2009-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M204501216AA0 | K092378 | 000 |
| M204501214AA0 | K092378 | 000 |
| M204501212AA0 | K092378 | 000 |
| M204501116AA0 | K092378 | 000 |
| M204501114AA0 | K092378 | 000 |
| M204501112AA0 | K092378 | 000 |
| M204501016AA0 | K092378 | 000 |
| M204501014AA0 | K092378 | 000 |
| M204501012AA0 | K092378 | 000 |