Central Venous Catheter
FDA 510(k) K870075 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK870075
Submission
- Device name
- Central Venous Catheter
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- January 8, 1987
- Decision date
- April 27, 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 Central Venous Catheter cleared by the FDA?
Central Venous Catheter (K870075) received a 510(k) decision of Substantially Equivalent on April 27, 1987, 109 days after the submission was received.
What is the product code of K870075?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.