Multilumen Central Venous Catheter
FDA 510(k) K885221 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK885221
Submission
- Device name
- Multilumen Central Venous Catheter
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Sandy, UT, US - Received
- December 20, 1988
- Decision date
- December 28, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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Questions and answers
When was Multilumen Central Venous Catheter cleared by the FDA?
Multilumen Central Venous Catheter (K885221) received a 510(k) decision of Substantially Equivalent on December 28, 1989, 373 days after the submission was received.
What is the product code of K885221?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.