Vacutainer Brand Plus Tube with Edta Anticoagulant(Multiple)
FDA 510(k) K971449 · Becton Dickinson Vacutainer Systems
510(k) numberK971449
Submission
- Device name
- Vacutainer Brand Plus Tube with Edta Anticoagulant(Multiple)
- Applicant
- Becton Dickinson Vacutainer Systems
Franklin Lake, NJ, US - Received
- April 21, 1997
- Decision date
- June 17, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GIM – Tubes, Vacuum Sample, With Anticoagulant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1675
- Specialty
- Clinical Chemistry
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|---|---|---|---|
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| K230493 | BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood…GIM · Traditional | Becton, Dickinson and Company | 11/27/2023SE |
| K213670 | BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection TubesGIM · Traditional | Becton, Dickinson and Company | 08/25/2023SE |
| K162723 | TransFix/EDTA Vacuum Blood Collection TubesGIM · Traditional | Caltag Medsystems, Ltd. | 06/22/2017SE |
| K080552 | Cyto-Chex BCTGIM · Traditional | Streck | 07/31/2008SE |
| K012152 | DS30 Hcy Blood Collection TubesGIM · Traditional | Drew Scientific , Ltd. | 09/18/2001SE |
| K971221 | Greiner Vacuette Blood Collection TubeGIM · Traditional | Greiner America, Inc. | 05/02/1997SE |
| K951886 | Lok-On Needle Disposal SystemGIM · Traditional | Becton Dickinson Vacutainer Systems | 06/30/1995SE |
| K945458 | Vacutainer Brand Safety-Gard Phlebotomy SystemGIM · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 02/06/1995SE |
| K944814 | Corvac Plastic Blood Collection TubeGIM · Traditional | Sherwood Medical Co. | 12/19/1994SE |
More from Sherwood Medical Co.
| 510(k) | Device | Decision |
|---|---|---|
| K002456 | Microtainer Brand Sodium Fluoride/Edta Tube with Microgard Closure, Model 365992JKA · Traditional | 11/02/2000SE |
| K991702 | Microtainer Brand Chemistry Tubes with Microgard Closure, Model 365965, 365985, 365963…JKA · Traditional | 07/28/1999SE |
| K991088 | Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and Safety-Lok…JKA · Traditional | 05/28/1999SE |
| K991120 | Vacutainer Brand Ctad Tube (Multiple)JKA · Traditional | 05/19/1999SE |
| K982541 | Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608FMI · Traditional | 10/28/1998SE |
| K982922 | Vacutainer Brand Blood Collection SyringeJKA · Traditional | 09/22/1998SE |
| K981013 | Vacutainer Plus Tube with Edta Anticoagulant Andd Vacutainer Plus Serum TubeJKA · Traditional | 06/17/1998SN |
| K972075 | Vacutainer Brand PPT Plasma Preparation TubePJE · Traditional | 02/24/1998SE |
| K980098 | Vacutainer Brand Pronto Needles HolderJKA · Traditional | 02/05/1998SE |
| K960250 | Vacutainer Brand Plus Serum & SST TubesJKA · Traditional | 03/29/1996SE |
Questions and answers
When was Vacutainer Brand Plus Tube with Edta Anticoagulant(Multiple) cleared by the FDA?
Vacutainer Brand Plus Tube with Edta Anticoagulant(Multiple) (K971449) received a 510(k) decision of Substantially Equivalent on June 17, 1997, 57 days after the submission was received.
What is the product code of K971449?
The FDA product code is GIM – Tubes, Vacuum Sample, With Anticoagulant, a Class II (moderate risk) device regulated under 21 CFR 862.1675.