Vascular Access Port/Catheter No.Vp-Xxx Vasport
FDA 510(k) K882969 · Gish Biomedical, Inc.
510(k) numberK882969
Submission
- Device name
- Vascular Access Port/Catheter No.Vp-Xxx Vasport
- Applicant
- Gish Biomedical, Inc.
Santa Ana, CA, US - Received
- July 15, 1988
- Decision date
- September 26, 1988
- 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 Vascular Access Port/Catheter No.Vp-Xxx Vasport cleared by the FDA?
Vascular Access Port/Catheter No.Vp-Xxx Vasport (K882969) received a 510(k) decision of Substantially Equivalent on September 26, 1988, 73 days after the submission was received.
What is the product code of K882969?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.