510(k) K954251
- Device
- 5F ENVOY GUIDING CATHETER (MODIFICATION)
- Applicant
- CORDIS NEUROVASCULAR, INC.
- 510(k) number
- K954251
- Product code
- DQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-10-23
- Date received
- 1995-08-24
- 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
- MARLENE WRIGHT VALENTI
- Address
- 14740 NW 60th Ave. Miami Lakes FL US 33014 33014
FDA Registration Numbers#
- 3009564766
- 3047894544
- 3030733800
- 3020954746
- 3031768596
- 3004091615
- 3005210579
- 3009380063
- 1220452
- 2518902
- 3001374820
- 3010041511
- 3009756153
- 2134265
- 3008110587
- 3006082230
- 3014162263
- 3012050423
- 1450662
- 9618000
- 3016171942
- 2030624
- 1828132
- 3008114965
- 8043892
- 3010882065
- 3025028711
- 3022392708
- 3005168196
- 3012536737
- 3014579161
- 3009051888
- 2648729
- 1313046
- 9616099
- 3035111606
- 2020394
- 1721504
- 3032277090
- 2648045
- 1061927
- 1225687
- 3009965866
- 2029214
- 3013944123
- 3016704395
- 1018233
- 3007284313
- 3027343398
- 3013764800
- 3003915875
- 3006131984
- 3009121749
- 3013557562
- 1625425
- 1643817
- 3011137372
- 8023054
- 2027111
- 9681834
- 3012102437
- 3002807090
- 3010273872
- 3003955307
- 9680794
- 9616684
- 3013288201
- 3014656749
- 2030598
- 2025870
- 2020735
- 3004742232
- 3015225571
- 2182208
- 2124215
- 3007695959
- 2649622
- 2183870
- 3001124136
- 3017210488
Source Documents#
Other 510(k) Records For Product Code DQY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262817 | CrossFAST Integrated Microcatheter Advanced Delivery System | Vantis Vascular, Inc. | 2026-09-18 |
| K260559 | NHanceIT | IMDS Operation B.V. | 2026-08-14 |
| K262392 | APRO 35 Swift Catheter | Alembic, LLC | 2026-08-12 |
| 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 |
Legacy Summary#
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FDA Review#
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