AC3 Range Intra-Aortic Balloon Pump
Arrow International, LLC · Cardiovascular
Open FDA's page for this record- Third party flag
- N
- City
- Morrisville
- Advisory committee description
- Cardiovascular
- Address 1
- (Subsidiary Of Teleflex Incorporated)
- Address 2
- 3015 Carrington Mill Blvd.
- Statement or summary
- Summary
- Product code
- DSP
- Zip code
- 27560
- Applicant
- Arrow International, LLC
- Decision date
- 2025-03-26
- Decision code
- SESE
- Country code
- US
- Device name
- AC3 Range Intra-Aortic Balloon Pump
- Advisory committee
- CV
- Contact
- Apurva Gokhale
- K number
- K250542
- State
- NC
- Date received
- 2025-02-24
- Review advisory committee
- CV
- Postal code
- 27560
- Decision description
- Substantially Equivalent
- Clearance type
- Special
- Harmonized identifiers (openFDA)
- Device name
- System, Balloon, Intra-Aortic And Control
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.3535
- Device class
- 2
- Registration number
- 3003263092, 3010155661, 2032677, 2183744, 3013320573, 3000126629, 1061124, 2031093, 3008496839, 3013162291, 3010041511, 3013596024, 3013500228, 3024894463, 1319639, 2249723, 2518435, 3009077524, 9680794, 2248146, 3007965489, 3015859709, 2011171, 3002807314, 3010532612, 9610816
- FEI number
- 3003263092, 3003945344, 3010155661, 1000512168, 3003737899, 3001236549, 1000222374, 2183744, 3013320573, 3000126629, 3001418283, 3008496839, 3013162291, 3010041511, 3002807167, 3013596024, 3013500228, 3024894463, 2518435, 3009077524, 1000138054, 3007965489, 3015859709, 2011171, 3002807314, 3010532612