Fogarty Arterial Embolectomy Catheter with Gate Valve
Edwards Lifesciences · Cardiovascular
Open FDA's page for this record- Third party flag
- N
- City
- Irvine
- Advisory committee description
- Cardiovascular
- Address 1
- 1 Edwards Way
- Statement or summary
- Summary
- Product code
- DXE
- Zip code
- 92614
- Applicant
- Edwards Lifesciences
- Decision date
- 2024-05-22
- Decision code
- SESE
- Country code
- US
- Device name
- Fogarty Arterial Embolectomy Catheter with Gate Valve
- Advisory committee
- CV
- Contact
- Yagna Angirish
- K number
- K233820
- State
- CA
- Date received
- 2023-12-01
- Review advisory committee
- CV
- Postal code
- 92614
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Catheter, Embolectomy
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.5150
- Device class
- 2
- Registration number
- 1724474, 2648045, 1220948, 3032916632, 2029386, 9617465, 9615817, 1820334, 2183870, 2027111, 2183744, 3015225571, 1721504, 1061124, 3030714660, 3045042524, 3035111606, 2024311, 3012536737, 8043983, 3010041511, 1000393132, 3033589330, 3011137372, 2522007, 3009051888, 1220452, 1319639, 1721686, 9616662, 2015691, 3006950086, 3012050423, 9680794, 3008496528, 1018233, 3005704822, 3013666218, 3015859709, 3006082230 +2 more
- FEI number
- 2648045, 1220948, 3032916632, 1000512168, 3003737899, 3003094851, 1820334, 2183870, 2027111, 2183744, 3016261803, 3015225571, 3000335778, 1721504, 3030714660, 3045042524, 3035111606, 1000306647, 2024311, 3012536737, 3010041511, 1000393132, 3003769549, 3033589330, 2522007, 3009051888, 3003081151, 1220452, 1721686, 2015691, 3006950086, 3012050423, 3008496528, 1018233, 1000138054, 3005704822, 3013666218, 3005747797, 3015859709, 3006082230 +2 more