510(k) K212719
- Device
- Micro Catheter and Guidewire System
- Applicant
- Suzhou Hengrui Hongyuan Medical Co., Ltd.
- 510(k) number
- K212719
- Product code
- KRA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-04-11
- Date received
- 2021-08-27
- Regulation
- 870.1210
- Classification name
- Catheter, Continuous Flush
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Wang Peipei
- Address
- Bldg. B9 Unit 201, # 218 Xinghu Rd., Sip Suzhou CN 215126 215126
FDA Registration Numbers
- 3010665433
- 3013858269
- 3043337628
- 3014687026
- 3031240343
- 9616662
- 3016927279
- 3008307705
- 2183870
- 3010909876
- 3015453963
- 2183744
- 3012536737
- 1644312
- 2134265
- 3012497308
- 1718873
- 3015550451
- 3013557562
- 2246552
- 3017823876
- 3014758755
- 9616684
- 1225687
- 1721676
- 1820334
- 3033589330
- 3006950086
- 3012307300
- 3010079067
- 1064858
- 3017210488
- 3017636737
- 3002807314
- 3007628272
- 1018233
- 3014644549
- 3038791046
- 3008881809
- 3030733800
- 1625425
- 3008514120
- 3012543881
- 3015489145
- 3013134719
- 3027395815
- 2648729
- 9615817
- 3020256033
- 3015151147
- 1713468
- 3013391155
- 3013556777
- 3007695959
- 1220948
- 1928237
- 1000393132
- 2531321
- 2183319
- 1724474
- 3021067373
- 1319639
- 3005160949
- 3023167283
- 3004142795
- 3003120897
- 3030481118
- 3010047454
- 3000126629
- 2030624
- 3005941719
- 3007156625
- 3015924373
- 9612501
- 2032112
- 1000523114
- 3026567963
- 9617601
- 3016948450
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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|---|---|---|---|
| K260771 | TruSelect 2.6 Microcatheter | Boston Scientific Corporation | 2026-05-15 |
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| K230636 | Maestro Microcatheter | Merit Medical System, Inc. | 2023-03-30 |
| K222679 | Vericor Support Catheter | Vascupatent Medical (Shenzhen) Co., Ltd. | 2022-11-07 |
| K213435 | MAGIC Flow-Dependent Microcatheter | Balt USA, LLC | 2022-07-19 |
| K213442 | Extroducer Infusion Catheter System | SmartWise Sweden AB | 2022-06-10 |
| K214025 | PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter | Medos International SARL | 2022-04-12 |
| K211110 | Agile Devices Angler Steerable, Deflectable Microcatheter | Agile Devices, Inc. | 2022-01-07 |