FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
CAREKITS(TM), IV/CATH/CENT LINE DRESS/TPN/CVP KITS
K Number: K903545
·
Decision Nov 13, 1990
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
7
Review Days
99
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
- CAREKITS(TM), IV/CATH/CENT LINE DRESS/TPN/CVP KITS
- K Number
- K903545
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Unknown
- Applicant
- J.J. Skinner, Inc.
- Date Received
- August 6, 1990
- Decision Date
- November 13, 1990
- Product Code
- FOZ
- 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 |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FOZ), ordered by most recent decision date.
Introcan Safety® Deep Access XL IV Catheter
FDA 510(k)
FDA Class 2
·General Hospital
BD Insyte IV Catheter
FDA 510(k)
FDA Class 2
·General Hospital
Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)
FDA 510(k)
FDA Class 2
·General Hospital
SURFLO Hybria Closed System Safety IV Catheter
FDA 510(k)
FDA Class 2
·General Hospital
Polyshield Safety IV Catheters
FDA 510(k)
FDA Class 2
·General Hospital
BD Saf-T-Intima Subcutaneous Catheter System
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by J.J. Skinner, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K961227 | JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TRAY | Jun 10, 1996 | Substantially Equivalent |
| K961683 | JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY | May 10, 1996 | Substantially Equivalent |
| K925469 | JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT | May 3, 1995 | Substantially Equivalent |
| K925467 | JJ SKINNER CAREKITS(TM) DRY/WET/GEL SKIN SCRUB KIT | May 11, 1994 | Unknown |
| K925468 | JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT | Apr 11, 1994 | Unknown |
| K903544 | CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS | Aug 31, 1990 | Unknown |