Devices for Vascu Intervent Rotat Hemostat Valve
FDA 510(k) K914422 · Devices For Vascular Intervention, Inc.
510(k) numberK914422
Submission
- Device name
- Devices for Vascu Intervent Rotat Hemostat Valve
- Applicant
- Devices For Vascular Intervention, Inc.
Redwood City, CA, US - Received
- October 3, 1991
- Decision date
- December 18, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
Other 510(k)s with product code DQY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260559 | NHanceITDQY · Traditional | IMDS Operation B.V. | 08/14/2026SE |
| K262392 | APRO 35 Swift CatheterDQY · Special | Alembic, LLC | 08/12/2026SE |
| K262240 | SSPC NXT Delivery CatheterDQY · Special | CenterPoint Systems, LLC | 07/29/2026SE |
| K261766 | CPS Locator 3D Plus Delivery CatheterDQY · Special | CenterPoint Systems, LLC | 07/29/2026SE |
| K261825 | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterDQY · Special | Abbott | 07/02/2026SE |
| K261631 | Amplatzer TorqVue Exchange SystemDQY · Special | Abbott Medical | 06/17/2026SE |
| K260289 | Perfect-O Ostial Positioning CatheterDQY · Traditional | Balosmark, Inc. | 06/05/2026SE |
| K260993 | Amplatzer TorqVue Delivery SystemDQY · Special | Abbott | 04/24/2026SE |
| K253361 | Teleport Glide MicrocatheterDQY · Traditional | OrbusNeich Medical (Shenzhen) Co., Ltd. | 04/10/2026SE |
| K260499 | Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/…DQY · Special | Abbott Medical | 03/13/2026SE |
More from Abbott Medical
| 510(k) | Device | Decision |
|---|---|---|
| K935929 | MicrotrackMCW · Traditional | 03/10/1994SE |
| K920707 | Hollow Motor Drive Unit W/ Torque ControllerMCW · Traditional | 11/23/1992SE |
| K911678 | Rotating Hemostatic ValveDYB · Traditional | 07/12/1991SE |
| K910205 | LP-60 Low Pressure Inflation DeviceMAV · Traditional | 02/25/1991SE |
| K901601 | Hollow Motor Drive UnitLIT · Traditional | 07/06/1990SE |
| K883933 | Introducing CatheterDYB · Traditional | 12/02/1988SE |
| K883981 | Guiding Catheter (Tip Softness Change)DWF · Traditional | 11/03/1988SE |
| K883916 | Rotating Hemostatic ValveDQY · Traditional | 10/28/1988SE |
| K883346 | Simpson Peripheral Atherocath W/Addit. Size 13FLIT · Traditional | 09/26/1988SE |
| K881088 | Addition of a Tip Guard to the Atherocath(Tm)LIT · Traditional | 05/31/1988SE |
Questions and answers
When was Devices for Vascu Intervent Rotat Hemostat Valve cleared by the FDA?
Devices for Vascu Intervent Rotat Hemostat Valve (K914422) received a 510(k) decision of Substantially Equivalent on December 18, 1991, 76 days after the submission was received.
What is the product code of K914422?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.