510(k) K153488
- Device
- Occlusion Perfusion Catheter
- Applicant
- Advanced Catheter Therapies, Inc.
- 510(k) number
- K153488
- Product code
- DQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-02-25
- Date received
- 2015-12-04
- Regulation
- 870.1250
- Classification name
- Catheter, Percutaneous
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Paul Joseph Fitzpatrick
- Address
- 25 E. Main St., Suite 205 Chattanooga TN US 37408 37408
FDA Registration Numbers#
- 1000523114
- 1721676
- 3003678543
- 2134265
- 9616662
- 3002807314
- 9681260
- 3015309643
- 3038791046
- 3012536737
- 1000121056
- 2246552
- 1319211
- 3010273872
- 3007695959
- 1724474
- 3033589330
- 3027595864
- 3015489145
- 3015225571
- 1721504
- 2124215
- 3006950086
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DQY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260993 | Amplatzer TorqVue Delivery System | Abbott | 2026-04-24 |
| K253361 | Teleport Glide Microcatheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2026-04-10 |
| K260499 | Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 | ABBOTT MEDICAL | 2026-03-13 |
| K253409 | C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) | Medtronic, Inc. | 2025-12-19 |
| K252417 | Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) | ABBOTT MEDICAL | 2025-12-17 |
| K252390 | Telescope Guide Extension Catheter | Medtronic, Ireland | 2025-10-29 |
| K250147 | CPS Locator 3D Delivery Catheter | Centerpoint Systems | 2025-08-22 |
| K251277 | CoraForce Microcatheter, CoraFlex Microcatheter | Reflow Medical, Inc. | 2025-08-22 |
| K250972 | Primum Hydrophilic Guiding Catheter | Pendracare | 2025-06-29 |
| K250828 | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | 2025-06-27 |
| K243184 | SAT CenterFlow Molding Balloon Catheter (IN20-00313) | Strait Access Technologies Holdings | 2025-06-25 |
| 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 |
Legacy Summary#
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FDA Review#
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