Bard Parker Thoracic Vent
FDA 510(k) K854634 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK854634
Submission
- Device name
- Bard Parker Thoracic Vent
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Paramus, NJ, US - Received
- November 19, 1985
- Decision date
- December 27, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KDQ – Bottle, Collection, Vacuum
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6740
- Specialty
- General Hospital
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Questions and answers
When was Bard Parker Thoracic Vent cleared by the FDA?
Bard Parker Thoracic Vent (K854634) received a 510(k) decision of Substantially Equivalent on December 27, 1985, 38 days after the submission was received.
What is the product code of K854634?
The FDA product code is KDQ – Bottle, Collection, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 880.6740.