FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
I.V. CATHETER
K Number: K772354
·
Decision Jan 31, 1978
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
11
Review Days
35
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
- I.V. CATHETER
- K Number
- K772354
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Ndm Corp.
- Date Received
- December 27, 1977
- Decision Date
- January 31, 1978
- 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 Ndm Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K926202 | CLEARSITE STERILE WOUND DRESSING, NDM WOUND DRESSI | May 12, 1993 | Substantially Equivalent |
| K901145 | NDM SWITCHPEN HOLSTER | May 9, 1990 | Substantially Equivalent |
| K853968 | DIATEMP ELECTROSURGICAL PEN | Nov 14, 1985 | Substantially Equivalent |
| K830663 | PENCIL SKIN ABRADER | Apr 28, 1983 | Substantially Equivalent |
| K810920 | NDM DIATEMP INFANT ELECTROSURG. DISP. P. | May 1, 1981 | Substantially Equivalent |
| K801158 | NDM DIATEMP ELECTROSURGICAL DIS. PAD | May 23, 1980 | Substantially Equivalent |
| K790730 | NDM PAPER TAPE ECG ELECTRODE | Apr 26, 1979 | Substantially Equivalent |
| K772160 | ELECTROSURGICAL GROUNDING PAD | Nov 28, 1977 | Substantially Equivalent |
| K761301 | V-TRACE ECG BACKPAD | Jan 5, 1977 | Substantially Equivalent |
| K760312 | ELECTRODE, PNS | Aug 4, 1976 | Substantially Equivalent |