510(k) K243184
- Device
- SAT CenterFlow Molding Balloon Catheter (IN20-00313)
- Applicant
- Strait Access Technologies Holdings
- 510(k) number
- K243184
- Product code
- DQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-06-25
- Date received
- 2024-09-30
- Regulation
- 870.1250
- Classification name
- Catheter, Percutaneous
- 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
- Malcolm Applewhite
- Address
- 313 Chris Barnard Bldg., Anzio Rd. Observatory 7925 Cape Town ZA
FDA Registration Numbers
- 3017168767
- 3010665433
- 1450662
- 3021951050
- 3002807090
- 3027343398
- 2521402
- 3014687026
- 3012050423
- 3020950818
- 9617592
- 1061124
- 3012266672
- 3025028711
- 2027062
- 3008307705
- 3006131984
- 2183870
- 3010909876
- 3015453963
- 2183744
- 3010291427
- 3012536737
- 3017708755
- 3010882065
- 3006260740
- 2134265
- 3007007790
- 1018470
- 3003910212
- 3016522967
- 3008700817
- 1318694
- 3012497308
- 3016591327
- 3015550451
- 3005012805
- 3001124136
- 9610139
- 9616099
- 3013557562
- 2024168
- 3007284313
- 3001374820
- 9616684
- 1225687
- 1721676
- 1820334
- 2939561
- 2017865
- 3008814558
- 3009766315
- 3007284006
- 3006425876
- 3006950086
- 3012307300
- 3033589330
- 3006451981
- 2017233
- 3013162291
- 3025341484
- 3010079067
- 1064858
- 3000247873
- 3017210488
- 2126666
- 2024024
- 3002807314
- 3007628272
- 3003915875
- 3012159165
- 3017262662
- 1018233
- 3009756327
- 3014644549
- 2649622
- 3032047719
- 3004742232
- 3008881809
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code DQY
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|---|---|---|---|
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| K252417 | Amplatzer Piccolo Delivery System (9-PDS-04F-045) | ABBOTT MEDICAL | 2025-12-17 |
| K252390 | Telescope Guide Extension Catheter | Medtronic, Ireland | 2025-10-29 |
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| K250972 | Primum Hydrophilic Guiding Catheter | Pendracare | 2025-06-29 |
| K250828 | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | 2025-06-27 |
| K250492 | FlexiGo 3D Delivery Catheter | CenterPoint Systems, LLC | 2025-06-18 |
| K250219 | Dorado PTA Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2025-06-17 |
| K250410 | GORE® Tri-Lobe Balloon Catheter | W. L. Gore & Associates, Inc. | 2025-06-02 |
| K243757 | Shockwave CS Guide Catheter | Shockwave Medical, Inc. | 2025-05-02 |
| K251014 | APRO 45 Catheter | Alembic, LLC | 2025-05-01 |