The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Inzone Detachment System, Model M00345100940, Izds Connecting Cable, Model M00345100250.
| Device ID | K092666 |
| 510k Number | K092666 |
| Device Name: | INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250 |
| Classification | Device, Neurovascular Embolization |
| Applicant | BOSTON SCIENTIFIC CORP. 47900 BAYSIDE PARKWAY Fremont, CA 94538 -6515 |
| Contact | James Leathley |
| Correspondent | James Leathley BOSTON SCIENTIFIC CORP. 47900 BAYSIDE PARKWAY Fremont, CA 94538 -6515 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-31 |
| Decision Date | 2009-09-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540675828 | K092666 | 000 |