Glidewire GT
FDA 510(k) K170417 · Terumo Corporation
510(k) numberK170417
Submission
- Device name
- Glidewire GT
- Applicant
- Terumo Corporation
Shibuya-Ku, JP - Received
- February 10, 2017
- Decision date
- September 15, 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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Questions and answers
When was Glidewire GT cleared by the FDA?
Glidewire GT (K170417) received a 510(k) decision of Substantially Equivalent on September 15, 2017, 217 days after the submission was received.
What is the product code of K170417?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.