FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BAXA TUBING SETS (FOR PHARMACY PUMP)
K Number: K872743
·
Decision Oct 9, 1987
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
747
Applicant Total
16
Review Days
88
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
- BAXA TUBING SETS (FOR PHARMACY PUMP)
- K Number
- K872743
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Baxa Corp., Sub. of Cook Group, Inc.
- Date Received
- July 13, 1987
- Decision Date
- October 9, 1987
- 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.
Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe
FDA 510(k)
FDA Class 2
·General Hospital
Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle
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
Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)
FDA 510(k)
FDA Class 2
·General Hospital
Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe
FDA 510(k)
FDA Class 2
·General Hospital
Instylla Delivery Kit
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Baxa Corp., Sub. of Cook Group, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K910257 | BAXA PCA INFUSOR | Nov 7, 1991 | Substantially Equivalent |
| K903159 | VALVE CONTROLLER FOR MICROMACRO COMPOUNDER | Nov 7, 1990 | Substantially Equivalent |
| K904225 | KWIKMIX | Nov 5, 1990 | Substantially Equivalent |
| K900585 | TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP | Apr 18, 1990 | Substantially Equivalent |
| K873875 | BAXA EXACTA-MED PHARMACY PUMP | Nov 24, 1987 | Substantially Equivalent |
| K844904 | CYTOSAFE NEEDLE | Feb 22, 1985 | Substantially Equivalent |
| K832332 | VENTED I.V. TRANSFER NEEDLE | Sep 12, 1983 | Substantially Equivalent |
| K832312 | I.V. TRANSFER NEEDLE | Sep 12, 1983 | Substantially Equivalent |
| K832347 | TWOFER NEEDLE | Sep 12, 1983 | Substantially Equivalent |
| K832254 | BAXA ADDISEAL | Jul 26, 1983 | Substantially Equivalent |