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 |