510(k) K915521
- Device
- TRACKER(R) UNIBODY CATH & TRACKER 25 CATH,MODIFIED
- Applicant
- TARGET THERAPEUTICS
- 510(k) number
- K915521
- Product code
- DQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-03-23
- Date received
- 1991-10-31
- 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
- ALEX BALL
- Address
- 130 Rio Robles P.O. Box 610458 San Jose CA US 95134 95134
FDA Registration Numbers#
- 2029214
- 9617601
- 2648045
- 3008837339
- 3015550451
- 3006550224
- 3007740583
- 9612164
- 3008423561
- 3016829855
- 1928237
- 1123137
- 1220477
- 3001124136
- 1531050
- 1016427
- 1625425
- 3008114965
- 1721504
- 3000268902
- 1646831
- 1047843
- 8043892
- 1526863
- 3017210488
- 1724474
- 2521402
- 3010432890
- 2030624
- 3032047719
- 3015859709
- 3016727301
- 2017865
- 1820334
- 2184009
- 3012497308
- 3005994106
- 3020954126
- 3003910212
- 3014498720
- 2649622
- 3008789872
- 1048735
- 1118880
- 3032916632
- 3026788751
- 1000563940
- 3007738736
- 3039062605
- 3007113487
- 3010273872
- 3005232773
- 3020954746
- 2648729
- 3003775027
- 3009756327
- 3003915875
- 3007207906
- 3004859241
- 3012159165
- 3014579161
- 3010370269
- 3024801436
- 3009564766
- 3013556777
- 2024311
- 2024168
- 3008824097
- 3012931345
- 3016704395
- 3015615738
- 1647149
- 3035111606
- 2953200
- 3008881809
- 2124215
- 3010291427
- 1643817
- 3013162291
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DQY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261825 | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter | Abbott | 2026-07-02 |
| K261631 | Amplatzer TorqVue Exchange System | Abbott Medical | 2026-06-17 |
| K260289 | Perfect-O Ostial Positioning Catheter | Balosmark, Inc. | 2026-06-05 |
| 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 |
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