FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORDGUARD BLOOD COLLECTION DEVICE
K Number: K912419
·
Decision Oct 5, 1992
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
35
Applicant Total
1
Review Days
493
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
- CORDGUARD BLOOD COLLECTION DEVICE
- K Number
- K912419
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- O.B. Tech., Inc.
- Date Received
- May 31, 1991
- Decision Date
- October 5, 1992
- Product Code
- HFW
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HFW | Clamp, Umbilical | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HFW), ordered by most recent decision date.
JOEY CLAMP OPENING TOOL
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
KAEN YIH UMBILICAL CORD CLAMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BUSSE UMBILICAL CORD CLAMP CUTTER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
KOALA CLAMP, KOALA CLAMP AND CUTTER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology