APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE— 510(k) DEN100026
UnknownAptus Endosystems, Inc.
FDA 510(k) clearance DEN100026 for APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE, Unknown on 2011-11-21. Applicant: Aptus Endosystems, Inc.. Device class: 2.
Clearance details
- Applicant
- Aptus Endosystems, Inc.
- Product code
- Code OTD
- Device class
- Class 2
- Regulation
- 21 CFR 870.3460
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Post-NSE
- Location
- Sunnyvale, CA, US
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More clearances from Aptus Endosystems, Inc.
view allAdverse events under product code OTD
product code OTD- Death
- 31
- Injury
- 172
- Total
- 203
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.