OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip
FDA 510(k) K202543 · Volcano Corporation
510(k) numberK202543
Submission
- Device name
- OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip
- Applicant
- Volcano Corporation
San Diego, CA, US - Received
- September 2, 2020
- Decision date
- September 28, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| 510(k) | Device | Decision |
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| K210235 | Verrata PLUS Pressure Guide WireDQX · Special | 04/15/2021SE |
| K203719 | IntraSight MobileIYO · Special | 01/19/2021SE |
| K192886 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm…DQX · Traditional | 03/26/2020SE |
| K190626 | SyncVision SystemOWB · Traditional | 04/12/2019SE |
| K190078 | IntraSightDSA · Special | 02/11/2019SE |
| K173860 | s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound…IYO · Traditional | 04/11/2018SE |
| K172455 | CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2…IYO · Special | 10/25/2017SE |
| K172574 | SyncVision SystemOWB · Traditional | 10/05/2017SE |
| K170385 | CORE M2 Vascular SystemIYO · Special | 04/06/2017SE |
| K160583 | REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short TipOBJ · Traditional | 10/26/2016SE |
Questions and answers
When was OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip cleared by the FDA?
OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip (K202543) received a 510(k) decision of Substantially Equivalent on September 28, 2020, 26 days after the submission was received.
What is the product code of K202543?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.