VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System
Luma Vision Limited · Cardiovascular
Open FDA's page for this record- Third party flag
- N
- City
- Dublin
- Advisory committee description
- Cardiovascular
- Address 1
- Block C, Parkview House-Beech Hill Office Campus
- Address 2
- Beech Hill Rd.
- Statement or summary
- Summary
- Product code
- OBJ
- Zip code
- D04 K5D0
- Applicant
- Luma Vision Limited
- Decision date
- 2025-03-24
- Decision code
- SESE
- Country code
- IE
- Device name
- VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System
- Advisory committee
- CV
- Contact
- Marta Walker
- K number
- K242893
- Date received
- 2024-09-23
- Review advisory committee
- CV
- Postal code
- D04 K5D0
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Catheter, Ultrasound, Intravascular
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.1200
- Device class
- 2
- Registration number
- 3005403518, 2030404, 3019807891, 3007695959, 1061124, 3010398867, 2090040, 3005334138, 3017060084, 3009196578, 3011137372, 9680579, 3019216, 9680794, 3006985147, 8010026, 3023245, 3012198618, 3007738736, 3016678045, 3013844297, 3009537152, 3013403214, 1058584, 3003594449, 3000126629, 3010273872, 3013944123, 8043817, 3033527241, 3035950510, 2024311, 2939520, 3010432890, 3013300026, 3014272734, 3032109181, 3009077524, 1000601180, 3038966633 +60 more
- FEI number
- 3005403518, 2828, 3003309342, 3019807891, 3003408255, 3007695959, 3003094575, 3002615969, 3010398867, 3005334138, 3002808529, 3017060084, 3009196578, 3000206435, 3019216, 3006985147, 3023245, 3003076831, 3012198618, 3007738736, 3002808327, 3016678045, 3013844297, 3002626007, 3009537152, 3003737899, 3013403214, 3003594449, 3000126629, 3010273872, 3013944123, 3033527241, 3035950510, 2024311, 2939520, 3010432890, 3013300026, 3014272734, 3032109181, 3009077524 +60 more