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FDA 510(k), K130904, TRELLIS-8 PERIPHERAL INFUSION SYSTEM
FDA 510(k), K130904, TRELLIS-8 PERIPHERAL INFUSION SYSTEM
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510(K) Number: K130904
Device Name: TRELLIS-8 PERIPHERAL INFUSION SYSTEM
Manufacturer: JENNIFER SULLIVAN
Device Classification Name: Mechanical Thrombolysis Catheter
Regulation Number: QEY
Classification Product Code: 04/01/2013
Date Received: 10/25/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: TRELLIS-8 PERIPHERAL INFUSION SYSTEM
Manufacturer: JENNIFER SULLIVAN
Device Classification Name: Mechanical Thrombolysis Catheter
Regulation Number: QEY
Classification Product Code: 04/01/2013
Date Received: 10/25/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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