Resolution Thrombectomy System, Model EV-2
FDA 510(k) K041705 · Omnisonics Medical Technologies
510(k) numberK041705
Submission
- Device name
- Resolution Thrombectomy System, Model EV-2
- Applicant
- Omnisonics Medical Technologies
Wilmington, MA, US - Received
- June 23, 2004
- Decision date
- September 1, 2004
- 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.
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More from AngioDynamics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K083335 | Modified Omniwave Endovascular SystemQEY · Special | 12/15/2008SE |
| K071762 | Omniwave Endovascular SystemQEY · Traditional | 09/27/2007SE |
| K052428 | Resolution Endovascular SystemQEY · Traditional | 12/08/2005SE |
| K003824 | Omnisonics Ultrasonic Surgery System, Model StiLFL · Traditional | 03/08/2001SE |
| K993628 | Omnisonics Ultrasonic ProbesLFL · Traditional | 12/15/1999SE |
| K993445 | Omnisonic Endoscopic DeflectorGCM · Traditional | 12/06/1999SE |
| K991377 | Omnisonics Flexible Fiber Optic Endoscope and CouplerGCJ · Traditional | 07/12/1999SE |
Questions and answers
When was Resolution Thrombectomy System, Model EV-2 cleared by the FDA?
Resolution Thrombectomy System, Model EV-2 (K041705) received a 510(k) decision of Substantially Equivalent on September 1, 2004, 70 days after the submission was received.
What is the product code of K041705?
The FDA product code is QEY – Mechanical Thrombolysis Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.5150.