FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYRINGE, BLOOD SAMPLING, ARTERIAL, #4016
K Number: K770851
·
Decision Jul 14, 1977
Classifications
1
FEI Numbers
553
Registration Numbers
553
Same Product Code
738
Applicant Total
42
Review Days
66
Basic Information
- Device Name
- SYRINGE, BLOOD SAMPLING, ARTERIAL, #4016
- K Number
- K770851
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- CONCORD LABORATORIES, INC.
- Date Received
- May 9, 1977
- Decision Date
- July 14, 1977
- Product Code
- FMF
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| FMF | Syringe, Piston | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMF), ordered by most recent decision date.
3DOSE 1ml Syringe
FDA 510(k)
FDA Class 2
·General Hospital
GPS Advanced; GPS Advanced Cannula
FDA 510(k)
FDA Class 2
·General Hospital
GO-PEN®
FDA 510(k)
FDA Class 2
·General Hospital
GraftGun Universal Graft Delivery System (GDS)
FDA 510(k)
FDA Class 2
·General Hospital
Insulin Syringes
FDA 510(k)
FDA Class 2
·General Hospital
Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by CONCORD LABORATORIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K883840 | DRI-VENT ARTERIAL BLOOD SAMPLING KIT | May 16, 1989 | Unknown |
| 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 |