Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter
Brosmed Medical Co., Ltd. · Cardiovascular
Open FDA's page for this record- Third party flag
- N
- City
- Dongguan
- Advisory committee description
- Cardiovascular
- Address 1
- 15th Bldg., Smes Venture Park Songshan Lake Hi-Tech
- Address 2
- Industrial Development Zone
- Statement or summary
- Summary
- Product code
- LIT
- Zip code
- 523808
- Applicant
- Brosmed Medical Co., Ltd.
- Decision date
- 2025-02-27
- Decision code
- SESE
- Country code
- CN
- Device name
- Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter
- Advisory committee
- CV
- Contact
- Crystal Lee
- K number
- K243704
- Date received
- 2024-11-29
- Review advisory committee
- CV
- Postal code
- 523808
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Catheter, Angioplasty, Peripheral, Transluminal
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.1250
- Device class
- 2
- Registration number
- 1313046, 3009018440, 3002806603, 3011471056, 9617592, 1055236, 1000533027, 2011171, 2024168, 2134626, 3016591327, 3048102902, 2030598, 3015002281, 3030574705, 3004091615, 3018805824, 3011088743, 3012448339, 2939561, 3008700817, 3007738736, 3004730544, 3016678045, 2020394, 1646831, 1000121056, 1820334, 3000247873, 2024024, 3010273872, 3014656749, 3013944123, 3030042169, 9618000, 3002807315, 9616666, 3010432890, 3014390222, 3011142981 +56 more
- FEI number
- 1313046, 3002806565, 3009018440, 3002806603, 3011471056, 1000533027, 2011171, 2024168, 3016591327, 3048102902, 3015002281, 3006003617, 3030574705, 1000138054, 3004091615, 3018805824, 3011088743, 3012448339, 3008700817, 3007738736, 3004730544, 3016678045, 2020394, 1000121056, 1820334, 3000247873, 2024024, 3010273872, 3014656749, 3013944123, 3030042169, 3002807315, 1000306139, 3010432890, 3014390222, 3011142981, 1000514656, 1000518731, 3019677404, 3003245778 +56 more