FDA 510(k)
FDA unclassified
Unknown
🇺🇸 United States
DRI-VENT ARTERIAL BLOOD SAMPLING KIT
K Number: K883840
·
Decision May 16, 1989
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
24
Applicant Total
42
Review Days
246
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
- DRI-VENT ARTERIAL BLOOD SAMPLING KIT
- K Number
- K883840
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Unknown
- Applicant
- Concord Laboratories, Inc.
- Date Received
- September 12, 1988
- Decision Date
- May 16, 1989
- Product Code
- LKB
- Advisory Committee
- Unknown
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LKB | Pad, Alcohol, Device Disinfectant | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LKB), ordered by most recent decision date.
PREVANTICS DEVICE SWAB
FDA 510(k)
FDA Unclassified
·Unknown
BD ALCOHOL SWAB
FDA 510(k)
FDA Unclassified
·Unknown
SITESCRUB IPA DEVICE
FDA 510(k)
FDA Unclassified
·Unknown
I.V. STARR KIT
FDA 510(k)
FDA Unclassified
·Unknown
STERI-SWAB
FDA 510(k)
FDA Unclassified
·Unknown
HEXIDIS ALCOHOL SWAB
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Concord Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K871825 | MECONIUM SUCTION CATHETER | Jun 29, 1987 | Substantially Equivalent |
| K864535 | TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110 | Jan 6, 1987 | Substantially Equivalent |
| K862039 | CONCORD CARE TRAY | Jul 3, 1986 | Unknown |
| K854601 | SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH | Jan 10, 1986 | Substantially Equivalent |
| K854327 | SUBCUTANEOUS TUNNELING NEEDLES & HANDLES | Nov 13, 1985 | Substantially Equivalent |
| K851134 | REGIONAL ANESTHESIA TRAYS | Jul 15, 1985 | Unknown |
| K842095 | EPIDURAL TRAYS | Jul 3, 1984 | Substantially Equivalent |
| K841486 | ARTERIAL BLOOD SAMPLING KITS | May 23, 1984 | Substantially Equivalent |
| K840986 | PREFILLED PULSATOR SYRINGE | Apr 5, 1984 | Substantially Equivalent |
| K840987 | VAPORIZED HEPARIN | Apr 5, 1984 | Substantially Equivalent |