510(k) K953265
- Device
- SCIMED ANGIOGRAPHIC KITS
- Applicant
- SCIMED LIFE SYSTEMS, INC.
- 510(k) number
- K953265
- Product code
- DQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-01-16
- Date received
- 1995-07-13
- 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
- No
Applicant Contact#
- Contact
- DIANE M LOWE
- Address
- One Scimed Pl. Maple Grove MN US 55311 55311
FDA Registration Numbers#
- 3003775027
- 3044156918
- 2518902
- 3008700817
- 3019807891
- 3016119728
- 9681834
- 9681477
- 3020950818
- 2024311
- 1526534
- 3008307705
- 3032277090
- 3005580113
- 3005012805
- 9616099
- 1319639
- 2528981
- 3015002281
- 3020954746
- 3015859709
- 1721504
- 8023054
- 3011088743
- 3004784537
- 3012931345
- 9681260
- 3012179728
- 3008627763
- 3006942602
- 2025870
- 3006425876
- 3003915875
- 1000563940
- 3003898360
- 1531050
- 3009051888
- 1722746
- 3005718570
- 3008789872
- 3020677060
- 3014687026
- 3014644549
- 2126666
- 3010079067
- 3012102437
- 3030236028
- 3006946276
- 3014656749
- 3006082230
- 3027319104
- 3004718255
- 3009756153
- 3013758550
- 3020954126
- 3005941719
- 3008264254
- 3016171942
- 3017278832
- 3015970743
- 3016540856
- 3010419931
- 1721676
- 9617601
- 2953200
- 3025028711
- 3003775186
- 3033589330
- 3013858269
- 3006451981
- 2020735
- 1000121056
- 3009905888
- 3003780911
- 1064858
- 3005334138
- 3013556777
- 3000247873
- 2017865
Source Documents#
Other 510(k) Records For Product Code DQY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261766 | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | 2026-07-29 |
| K262240 | SSPC NXT Delivery Catheter | CenterPoint Systems, LLC | 2026-07-29 |
| 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 |
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