510(k) K950634
- Device
- CANDELA SHEATH SETS
- Applicant
- CANDELA LASER CORP.
- 510(k) number
- K950634
- Product code
- DQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-03-01
- Date received
- 1995-02-13
- 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
- THOMAS R VARRICCHIONE
- Address
- 530 Boston Post Rd. Wayland MA US 01778 01778
FDA Registration Numbers#
- 3016704395
- 2648045
- 3012543881
- 3000268902
- 3027058844
- 2953200
- 1313046
- 3009766315
- 3016829855
- 3020954746
- 3009018440
- 3012159165
- 3025341484
- 3008837339
- 2025870
- 3019807891
- 3002806603
- 3007695959
- 3006946276
- 3027319104
- 9617592
- 3008881809
- 1061124
- 3006425876
- 2017865
- 3005334138
- 3035111606
- 3008110587
- 2134812
- 2024168
- 1722746
- 3008114965
- 3016591327
- 3009756153
- 3004111573
- 3016522967
- 2030598
- 3011137372
- 3015002281
- 3033589330
- 3046434506
- 1526863
- 3013764800
- 3006260740
- 3001124136
- 3016948450
- 3044156918
- 3012497308
- 3014644549
- 9680794
- 1625425
- 3016119728
- 2020735
- 8010026
- 3020347218
- 3005168196
- 2135147
- 2523676
- 3004091615
- 3011088743
- 3030088112
- 3012448339
- 3008700817
- 2939561
- 3021951050
- 3007740583
- 3016727301
- 3038912532
- 3017278832
- 3007738736
- 3006942602
- 3008307705
- 3015550451
- 3016678045
- 2020394
- 2649622
- 1646831
- 3010155661
- 3032916632
- 1000121056
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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