510(k) K110055
- Device
- REVERSE MEDICAL REFLEX GUIDE CATHETER
- Applicant
- REVERSE MEDICAL CORPORATION
- 510(k) number
- K110055
- Product code
- DQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-04-05
- Date received
- 2011-01-10
- 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
- Yes
Applicant Contact#
- Contact
- AMY ESKINA
- Address
- 13700 Alton Pkwy., Suite 167 Irvine CA US 92618 92618
FDA Registration Numbers#
- 1724474
- 3010432890
- 3006082230
- 3010665433
- 1016427
- 2182269
- 3016678045
- 3007007790
- 3013162291
- 3009051888
- 3012307300
- 3000247873
- 1225687
- 3014590708
- 3006425876
- 9617592
- 3009546466
- 1028232
- 3031768596
- 9680794
- 3016948450
- 3004111573
- 3025028711
- 3014498720
- 3012536737
- 3017168767
- 3005168196
- 2011171
- 2518902
- 3016171942
- 3009121749
- 3008814558
- 2126666
- 3016444913
- 3003955307
- 3006942602
- 3030733800
- 3014211783
- 1058584
- 3011137372
- 9616684
- 3019751610
- 3008627763
- 1313046
- 3008881809
- 3011142981
- 3035111606
- 3015615738
- 3017262662
- 3005255160
- 2134812
- 3003780911
- 3000268902
- 2017233
- 2648045
- 3009756327
- 3004415014
- 3006550224
- 3014766734
- 3014461810
- 3004784537
- 3012154226
- 3005210579
- 3017210488
- 2184009
- 3027058844
- 3008110587
- 2183870
- 2134265
- 3014579161
- 3039062605
- 3007882731
- 3015550451
- 3010041511
- 3009144177
- 3008789872
- 3021951050
- 3012543881
- 2648729
Source Documents#
Other 510(k) Records For Product Code DQY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K251277 | CoraForce Microcatheter, CoraFlex Microcatheter | Reflow Medical, Inc. | 2025-08-22 |
| K250147 | CPS Locator 3D Delivery Catheter | Centerpoint Systems | 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 |
| K243184 | SAT CenterFlow Molding Balloon Catheter (IN20-00313) | Strait Access Technologies Holdings | 2025-06-25 |
| K250492 | FlexiGo 3D Delivery Catheter | CenterPoint Systems, LLC | 2025-06-18 |
Legacy Summary#
summary
FDA Review#
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