510(k) K952872
- Device
- SSCIMED CORONARY GUIDE WIRE/INFUSION CATHETER
- Applicant
- SCIMED LIFE SYSTEMS, INC.
- 510(k) number
- K952872
- Product code
- KRA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-07-27
- Date received
- 1995-05-10
- 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
- No
Applicant Contact#
- Contact
- SHERRY L SPARROW
- Address
- One Scimed Pl. Maple Grove MN US 55311 55311
FDA Registration Numbers#
- 3044156918
- 9681834
- 3019807891
- 3040099838
- 1644312
- 2024311
- 1282497
- 1713468
- 3008307705
- 3040801290
- 3027395815
- 3038791046
- 1000393132
- 1319639
- 1721504
- 3003120897
- 8023054
- 2531321
- 9681260
- 1718873
- 3020256033
- 3010334444
- 3007695959
- 2183319
- 3015924373
- 3014687026
- 3014644549
- 3010079067
- 3006946276
- 3009500972
- 3006082230
- 3009756153
- 8020616
- 3031976597
- 3005941719
- 3008264254
- 1721676
- 9617601
- 3033589330
- 3013858269
- 1000121056
- 1064858
- 3013556777
- 3015151147
- 9616567
- 3014211783
- 3012543881
- 3017208642
- 1319211
- 3010220595
- 3015550451
- 3004111573
- 3012497308
- 3016927279
- 3004142795
- 3021067373
- 2134812
- 9617594
- 3014162263
- 3014787927
- 3027595864
- 3002806337
- 3013557562
- 1220477
- 2124215
- 2029214
- 2246552
- 3008881809
- 3010041511
- 9612501
- 3007628272
- 3013134719
- 3043337628
- 1820334
- 3015225571
- 3030574705
- 3007156625
- 3014779787
- 2030624
Source Documents#
Other 510(k) Records For Product Code KRA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261610 | Verge™ Microcatheter | Instylla, Inc. | 2026-06-11 |
| K260771 | TruSelect™ 2.6 Microcatheter | Boston Scientific Corporation | 2026-05-15 |
| K250794 | InVera Infusion Device | Invera Medical | 2026-03-12 |
| K243534 | Micro Catheter | Suzhou Zenith Vascular SciTech Limited | 2025-07-30 |
| K231821 | XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,) | Transit Scientific, LLC | 2023-11-29 |
| K231279 | Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm | Ablative Solutions, Inc. | 2023-07-05 |
| K231148 | ScleroSafe™ 150 mm, ScleroSafe™ 350 mm | Vvt Medical , Ltd. | 2023-06-20 |
| K230957 | TriSalus TriNav® LV Infusion System | Trisalus Life Sciences | 2023-05-02 |
| K223139 | Wallaby 017 Micro Catheter | Wallaby Medical | 2023-04-25 |
| K223176 | Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ Aspiration Canister | Argon Medical Devices, Inc. | 2023-04-10 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases