Firebow Wire Torque Assist Device
FDA 510(k) K170684 · Vesatek, LLC
510(k) numberK170684
Submission
- Device name
- Firebow Wire Torque Assist Device
- Applicant
- Vesatek, LLC
Irvine, CA, US - Received
- March 7, 2017
- Decision date
- June 29, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQX – Wire, Guide, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1330
- Specialty
- Cardiovascular
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More from Solo Pace, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K200120 | LiteSaber Wire Torque Assist DeviceDQX · Traditional | 05/07/2020SE |
Questions and answers
When was Firebow Wire Torque Assist Device cleared by the FDA?
Firebow Wire Torque Assist Device (K170684) received a 510(k) decision of Substantially Equivalent on June 29, 2017, 114 days after the submission was received.
What is the product code of K170684?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.