Synchro2 Support Guidewire
FDA 510(k) K190843 · Stryker
510(k) numberK190843
Submission
- Device name
- Synchro2 Support Guidewire
- Applicant
- Stryker
Fremont, CA, US - Received
- April 1, 2019
- Decision date
- May 1, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MOF – Guide, Wire, Catheter, Neurovasculature
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1330
- Specialty
- Cardiovascular
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Questions and answers
When was Synchro2 Support Guidewire cleared by the FDA?
Synchro2 Support Guidewire (K190843) received a 510(k) decision of Substantially Equivalent on May 1, 2019, 30 days after the submission was received.
What is the product code of K190843?
The FDA product code is MOF – Guide, Wire, Catheter, Neurovasculature, a Class II (moderate risk) device regulated under 21 CFR 870.1330.