Sterile High-pressure Angiographic Syringes for single-use
FDA 510(k) clearance K201395 · decided 2020-10-28
Clearance details
- K-number
- K201395
- Device name
- Sterile High-pressure Angiographic Syringes for single-use
- Applicant
- Youwo (Guangzhou) Medical Device Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-05-27
- Decision date
- 2020-10-28
- Days to decision
- 154 days
- Clearance type
- Traditional
- Product code
- DXT
- Device class
- 2
- Regulation number
- 870.1650
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Guangzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.