FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TERUMO VENOJECT,LUER ADAPTER
K Number: K983490
·
Decision Nov 30, 1998
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
235
Applicant Total
21
Review Days
56
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
- TERUMO VENOJECT,LUER ADAPTER
- K Number
- K983490
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Terumo Corp.
- Date Received
- October 5, 1998
- Decision Date
- November 30, 1998
- 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 Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K100282 | TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER | Feb 26, 2010 | Substantially Equivalent |
| K092372 | HEARTRAIL III GUIDING CATHETER | Sep 11, 2009 | Substantially Equivalent |
| K091417 | SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A | May 22, 2009 | Substantially Equivalent |
| K090973 | TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES) | May 1, 2009 | Substantially Equivalent |
| K073474 | CAPIOX CIRCUIT CONNECTORS | Mar 5, 2008 | Substantially Equivalent |
| K071572 | CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER | Jul 23, 2007 | Substantially Equivalent |
| K071494 | CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER | Jul 16, 2007 | Substantially Equivalent |
| K071075 | TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A | May 25, 2007 | Substantially Equivalent |
| K040783 | FOUNDATION | Oct 13, 2004 | Substantially Equivalent |
| K040210 | CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR | Mar 3, 2004 | Substantially Equivalent |