UltraCor Twirl Breast Tissue Marker
Bard Peripheral Vascular, Inc. · General, Plastic Surgery
Open FDA's page for this record- Third party flag
- N
- City
- Tempe
- Advisory committee description
- General, Plastic Surgery
- Address 1
- 1625 W. 3rd St.
- Statement or summary
- Summary
- Product code
- NEU
- Zip code
- 85281
- Applicant
- Bard Peripheral Vascular, Inc.
- Decision date
- 2025-03-24
- Decision code
- SESE
- Country code
- US
- Device name
- UltraCor Twirl Breast Tissue Marker
- Advisory committee
- SU
- Contact
- Meghan McKelvey
- K number
- K243642
- State
- AZ
- Date received
- 2024-11-26
- Review advisory committee
- SU
- Postal code
- 85281
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Marker, Radiographic, Implantable
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.4300
- Device class
- 2
- Registration number
- 3018094310, 3021008900, 1835568, 3007366790, 3019807891, 3021179744, 2032338, 3010813819, 3006981798, 3004111573, 3011245468, 3014653199, 3033589330, 2936485, 3015924373, 1625425, 3012644426, 3014090621, 3011162972, 3007738736, 3008236846, 3016678045, 2020394, 3009039068, 1000486410, 3036009309, 3030733800, 3015225571, 3015207155, 3000126629, 3004636440, 3009609358, 3033536844, 1825034, 3014967969, 9617429, 3002907620, 2022435, 3009077524, 1018233 +61 more
- FEI number
- 3018094310, 3021008900, 3019807891, 3003295907, 3021179744, 3010813819, 3006981798, 3007282753, 1000434163, 3004111573, 3011245468, 3014653199, 3033589330, 2936485, 3015924373, 1625425, 3003367650, 3012644426, 3014090621, 3011162972, 3001237677, 3007738736, 3008236846, 3016678045, 2020394, 3002807584, 3009039068, 1000486410, 3036009309, 3030733800, 3003094851, 3015225571, 3015207155, 3000126629, 3004636440, 3009609358, 1000306139, 3033536844, 1825034, 3014967969 +61 more