510(k) K871080
- Device
- PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
- Applicant
- CATHETER TECHNOLOGY CORP.
- 510(k) number
- K871080
- Product code
- DQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-08-12
- Date received
- 1987-03-18
- Regulation
- 870.1250
- Classification name
- Catheter, Percutaneous
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- COLIN J NICHOLS
- Address
- 3385 W. 1820 S. Salt Lake City UT US 84104 84104
FDA Registration Numbers#
- 9617601
- 3009018440
- 1721676
- 3015859709
- 2024168
- 3012159165
- 3003955307
- 3013288201
- 3006946276
- 3013134719
- 2518902
- 3007628272
- 3012543881
- 3014579161
- 3008789872
- 3027319104
- 3004742232
- 3013556777
- 1721504
- 3010419931
- 3009888344
- 3012266672
- 3014590708
- 3014461810
- 3013162291
- 3016727301
- 3004859241
- 3007882731
- 3013764800
- 9681477
- 3004784537
- 3004063494
- 2184009
- 2020394
- 3008264254
- 3004091615
- 2020735
- 3021951050
- 3032916632
- 3003610571
- 2134265
- 3030733800
- 3015550451
- 1647149
- 3011088743
- 3014779787
- 3020954746
- 3005070406
- 3015002281
- 3017262662
- 3005941719
- 3020677060
- 9617592
- 3005994106
- 3007284313
- 1526534
- 3006550224
- 3020347218
- 2024311
- 2648045
- 2017865
- 3010370269
- 3003898360
- 3017168767
- 2528981
- 3010421104
- 3008700817
- 3012448339
- 3035111606
- 1220452
- 3009121749
- 3027058844
- 3002806603
- 9616684
- 3002807314
- 1646831
- 1526863
- 3014211783
- 3012497308
- 3016948450
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DQY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K251277 | CoraForce Microcatheter, CoraFlex Microcatheter | Reflow Medical, Inc. | 2025-08-22 |
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