Vac-Rite Sunction Collection
FDA 510(k) K811192 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK811192
Submission
- Device name
- Vac-Rite Sunction Collection
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Washington, DC, US - Received
- April 30, 1981
- Decision date
- June 2, 1981
- 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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| K993186 | Synercid, 15 Ug, BBL Sensi-DiscJTN · Traditional | 11/03/1999SE |
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Questions and answers
When was Vac-Rite Sunction Collection cleared by the FDA?
Vac-Rite Sunction Collection (K811192) received a 510(k) decision of Substantially Equivalent on June 2, 1981, 33 days after the submission was received.
What is the product code of K811192?
The FDA product code is KDQ – Bottle, Collection, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 880.6740.