Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter
Zylox Medtech Co., Ltd. · Cardiovascular
Open FDA's page for this record- Third party flag
- N
- City
- Hangzhou
- Advisory committee description
- Cardiovascular
- Address 1
- Rm. 406, 4th Floor, Block B, # 270, Shuyun Rd.,
- Address 2
- Cangqian Sub-District, Yuhang District
- Statement or summary
- Summary
- Product code
- PNO
- Zip code
- 311121
- Applicant
- Zylox Medtech Co., Ltd.
- Decision date
- 2026-10-22
- Decision code
- SESE
- Country code
- CN
- Device name
- Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter
- Advisory committee
- CV
- Contact
- Wanying Xie
- K number
- K260686
- Date received
- 2026-03-03
- Review advisory committee
- CV
- Postal code
- 311121
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Catheter, Percutaneous, Cutting/Scoring
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.1250
- Device class
- 2
- Registration number
- 1647149, 2020394, 1646831, 1313046, 8043792, 2124215, 3012159165, 3011826338, 1820334, 3000247873, 2183744, 3027343398, 3021140368, 3000126629, 3030042169, 1000533027, 3007835716, 3002807315, 3048102902, 3009756153, 9681260, 3015060261, 3015002281, 3016948450, 3014598164, 3010391265, 3003775186, 1018233, 3012696653, 1721676, 3006082230, 2011171, 3002807314, 3005462046
- FEI number
- 2020394, 1000160215, 1313046, 3002806565, 2124215, 3012159165, 3011826338, 1820334, 3000247873, 2183744, 3027343398, 3021140368, 3002808269, 3000126629, 3030042169, 1000533027, 3007835716, 3002807315, 1000306139, 3048102902, 3009756153, 3015060261, 3015002281, 3016948450, 3014598164, 3010391265, 3003775186, 1018233, 3012696653, 1721676, 3006082230, 2011171, 3002807314, 3005462046