510(k) K861008
- Device
- PERCUTANEOUS CATHETERS
- Applicant
- MICOR, INC.
- 510(k) number
- K861008
- Product code
- DQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-04-29
- Date received
- 1986-03-18
- 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
- STEPHEN BRUSHEY
- Address
- 9229 Pannier Rd. Pittsburgh PA US 15237 15237
FDA Registration Numbers#
- 3016591327
- 9680794
- 3010155661
- 1220452
- 3012154226
- 3014779787
- 3000126629
- 1828132
- 1225687
- 3024801436
- 3006946276
- 3020954746
- 3006082230
- 1646831
- 3008307705
- 3000268902
- 2183787
- 3009756327
- 3004784537
- 3007207906
- 3008700817
- 3035111606
- 3005168196
- 3015225571
- 2030598
- 3009144177
- 3011706110
- 3013858269
- 9616684
- 1526534
- 3005210579
- 3001124136
- 3016727301
- 3032916632
- 3010909876
- 3002806603
- 2183870
- 3014162263
- 3008261722
- 3015002281
- 3016948450
- 3002807090
- 3009888344
- 3009121749
- 3014211783
- 3016522967
- 3016829855
- 3012279212
- 3032047719
- 1313046
- 3009051888
- 3019807891
- 3005232773
- 3015550451
- 3012266672
- 3015970743
- 3007628272
- 3015453963
- 3013944123
- 2024311
- 1721676
- 1220477
- 2528981
- 3004415014
- 3006425876
- 3014687026
- 1058584
- 3006550224
- 3007284006
- 3004111573
- 3012497308
- 3016678045
- 3016119728
- 3015309643
- 3020677060
- 9681834
- 3005580113
- 3046434506
- 3012536737
- 3007113487
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