Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set
FDA 510(k) clearance K142297 · decided 2015-01-08
Clearance details
- K-number
- K142297
- Device name
- Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set
- Applicant
- Xeridiem (Formerly Mri)
- Decision
- Substantially Equivalent
- Date received
- 2014-08-18
- Decision date
- 2015-01-08
- Days to decision
- 143 days
- Clearance type
- Traditional
- Product code
- PIF
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Tucson, AZ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.