FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VENOJECT II BLOOD COLLECTION TUBES
K Number: K900309
·
Decision Mar 15, 1990
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
235
Applicant Total
143
Review Days
52
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- VENOJECT II BLOOD COLLECTION TUBES
- K Number
- K900309
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Terumo Medical Corp.
- Date Received
- January 22, 1990
- Decision Date
- March 15, 1990
- Product Code
- JKA
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JKA), ordered by most recent decision date.
Female Culture Device; Male Culture Device; Transfer Device; Access Device
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD Preset and BD A-Line Arterial Blood Collection Syringes
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Steripath® Flow Blood Collection System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Terumo Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K111606 | PINNACLE PRECISION ACCESS SYSTEM | Oct 3, 2011 | Substantially Equivalent |
| K111556 | GLIDECROSS SUPPORT CATHETER | Jul 29, 2011 | Substantially Equivalent |
| K110540 | TERUMO SUPPORT CATHETER | May 13, 2011 | Substantially Equivalent |
| K102008 | GLIDESHEATH | Jul 21, 2010 | Substantially Equivalent |
| K091329 | PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH | May 29, 2009 | Substantially Equivalent |
| K082997 | TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER | Apr 15, 2009 | Substantially Equivalent |
| K090040 | RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) | Feb 6, 2009 | Substantially Equivalent |
| K082847 | PINNACLE ROII INTRODUCER SHEATH | Oct 29, 2008 | Substantially Equivalent |
| K082519 | FINECROSS MG CORONARY MICRO-GUIDE CATHETER | Sep 26, 2008 | Substantially Equivalent |
| K082736 | RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER | Sep 24, 2008 | Substantially Equivalent |