FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYRINGE TIP CAP
K Number: K911638
·
Decision Jun 21, 1991
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
235
Applicant Total
23
Review Days
71
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
- SYRINGE TIP CAP
- K Number
- K911638
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Concord/Portex
- Date Received
- April 11, 1991
- Decision Date
- June 21, 1991
- 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 Concord/Portex
| K Number | Device Name | ||
|---|---|---|---|
| K923559 | STERI-CATH MDI | Oct 25, 1993 | Substantially Equivalent |
| K930218 | SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES | Jul 27, 1993 | Substantially Equivalent |
| K924541 | EPIDURAL MINIPACK | Jul 9, 1993 | Unknown |
| K930286 | DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS | Jun 22, 1993 | Unknown |
| K923127 | NEEDLE-PRO CARTRIDGE | Apr 29, 1993 | Substantially Equivalent |
| K923910 | HEAT MOISTURE CONDENSER | Jan 26, 1993 | Substantially Equivalent |
| K922749 | LOW PROFILE TRACHEOSTOMY TUBE | Sep 2, 1992 | Substantially Equivalent |
| K922445 | VACU-PRO | Aug 12, 1992 | Substantially Equivalent |
| K915452 | ANESTHESIA BREATHING CIRCUIT | Feb 14, 1992 | Substantially Equivalent |
| K911809 | NEW-VENT | Aug 26, 1991 | Substantially Equivalent |