Ven-A-Cath Percutaneous Venous Catheter Kit
FDA 510(k) K881504 · Hdc Corp.
510(k) numberK881504
Submission
- Device name
- Ven-A-Cath Percutaneous Venous Catheter Kit
- Applicant
- Hdc Corp.
Mountain View, CA, US - Received
- April 11, 1988
- Decision date
- June 22, 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 Ven-A-Cath Percutaneous Venous Catheter Kit cleared by the FDA?
Ven-A-Cath Percutaneous Venous Catheter Kit (K881504) received a 510(k) decision of Substantially Equivalent on June 22, 1988, 72 days after the submission was received.
What is the product code of K881504?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.