Subclavian, Gish Model No. Svac-Xxxx
FDA 510(k) K863791 · Gish Biomedical, Inc.
510(k) numberK863791
Submission
- Device name
- Subclavian, Gish Model No. Svac-Xxxx
- Applicant
- Gish Biomedical, Inc.
Santa Ana, CA, US - Received
- September 26, 1986
- Decision date
- June 25, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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Questions and answers
When was Subclavian, Gish Model No. Svac-Xxxx cleared by the FDA?
Subclavian, Gish Model No. Svac-Xxxx (K863791) received a 510(k) decision of Substantially Equivalent on June 25, 1987, 272 days after the submission was received.
What is the product code of K863791?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.