Spiralfuse Peripheral Infusion System
FDA 510(k) K082199 · Bacchus Vascular, Inc.
510(k) numberK082199
Submission
- Device name
- Spiralfuse Peripheral Infusion System
- Applicant
- Bacchus Vascular, Inc.
Santa Clara, CA, US - Received
- August 4, 2008
- Decision date
- October 17, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QEY – Mechanical Thrombolysis Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5150
- Specialty
- Cardiovascular
To mechanically disrupt thrombus and/or debris in the peripheral vasculature.
Other 510(k)s with product code QEY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260149 | Versus Catheter (VS110-9NB)QEY · Special | Liquet Medical, Inc. | 02/17/2026SE |
| K251318 | VariFuse Adjustable Infusion CatheterQEY · Traditional | Argon Medical Devices, Inc. | 01/20/2026SE |
| K241851 | Versus Catheter (VS110-8B)QEY · Traditional | Liquet Medical, Inc. | 11/25/2024SE |
| K231653 | BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular CatheterQEY · Special | Thrombolex, Inc. | 07/03/2023SE |
| K222095 | BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No.…QEY · Traditional | Thrombolex, Inc. | 04/20/2023SE |
| K220866 | EKOS+ Endovascular DeviceQEY · Special | Boston Scientific | 04/20/2022SE |
| K213422 | EkoSonic Endovascular Device, EKOS+ Endovascular DeviceQEY · Traditional | Boston Scientific Corporation | 12/14/2021SE |
| K211080 | EkoSonic Endovascular DeviceQEY · Traditional | Boston Scientific | 11/19/2021SE |
| K211061 | BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref.…QEY · Traditional | Thrombolex, Inc. | 06/10/2021SE |
| K202347 | UNIFUSE Infusion System with Cooper WireQEY · Special | AngioDynamics, Inc. | 09/15/2020SE |
More from AngioDynamics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K071664 | TRELLIS-6 Peripheral Infusion SystemQEY · Special | 07/13/2007SE |
| K050147 | TRELLIS-8 Peripheral Infusion SystemQEY · Special | 02/03/2005SE |
| K033997 | Solera Plus Thrombectomy Catheter, 55 CM and 110 CM, Models Bac SMG 007 055, Bac SMG 007…MCW · Special | 02/04/2004SE |
| K032261 | Trellis Reserve Infusion SystemQEY · Special | 08/22/2003SE |
| K023514 | TRELLIS-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion Length)QEY · Traditional | 12/02/2002SE |
| K022640 | Solera Magnum Thrombectomy Catheter, 55 CM, Model Bac SMG 007 055 & Solera Magnum…MCW · Special | 12/02/2002SE |
| K021958 | Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM (100CM…QEY · Special | 07/03/2002SE |
| K013635 | Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM Infusion…QEY · Traditional | 02/11/2002SE |
| K003570 | Bacchus Thrombectomy Catheter (BTC), Model BTC-0755MCW · Traditional | 06/06/2001SE |
Questions and answers
When was Spiralfuse Peripheral Infusion System cleared by the FDA?
Spiralfuse Peripheral Infusion System (K082199) received a 510(k) decision of Substantially Equivalent on October 17, 2008, 74 days after the submission was received.
What is the product code of K082199?
The FDA product code is QEY – Mechanical Thrombolysis Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.5150.