NC PTA Balloon Dilatation Catheter
Kossel Medtech (Suzhou) Co., Ltd. · Cardiovascular
Open FDA's page for this record- Third party flag
- N
- City
- Suzhou New District
- Advisory committee description
- Cardiovascular
- Address 1
- Bldg. 6,# 8 Jinfeng Rd.
- Statement or summary
- Summary
- Product code
- LIT
- Zip code
- 215163
- Applicant
- Kossel Medtech (Suzhou) Co., Ltd.
- Decision date
- 2026-09-16
- Decision code
- SESE
- Country code
- CN
- Device name
- NC PTA Balloon Dilatation Catheter
- Advisory committee
- CV
- Contact
- Haifeng Xie
- K number
- K254212
- Date received
- 2025-12-29
- Review advisory committee
- CV
- Postal code
- 215163
- 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
- 9616666, 3005580113, 3012050423, 9617592, 3010220595, 1000121056, 3014222368, 1820334, 3013391155, 3008700817, 1647149, 3011471056, 3005994106, 1643817, 2020394, 3009965866, 2134265, 3019677404, 9617601, 1000563940, 3010291427, 1220452, 3003775186, 1018233, 3013944123, 3010273872, 2024024, 3008361782, 3048102902, 1000393132, 2124215, 2134626, 1016427, 1318694, 2024168, 3006550224, 3027395815, 3011142981, 3015910259, 3022627847 +53 more
- FEI number
- 3005580113, 3012050423, 3010220595, 1000121056, 1000514656, 3014222368, 1820334, 3013391155, 3008700817, 3011471056, 3005994106, 1643817, 2020394, 3002808050, 1000518731, 3009965866, 1000112877, 3019677404, 3003245778, 1000563940, 3010291427, 1000160215, 3002806565, 1220452, 3003775186, 3002468371, 1018233, 3013944123, 3010273872, 2024024, 3008361782, 3048102902, 1000393132, 2124215, 1016427, 1318694, 2024168, 3002808904, 3006550224, 3027395815 +53 more