FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VEN-A-CATH PERCUTANEOUS VENOUS CATHETER KIT
K Number: K881504
·
Decision Jun 22, 1988
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
30
Review Days
72
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Basic Information
- Device Name
- VEN-A-CATH PERCUTANEOUS VENOUS CATHETER KIT
- K Number
- K881504
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Hdc Corp.
- Date Received
- April 11, 1988
- Decision Date
- June 22, 1988
- Product Code
- DQY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| K002770 | IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-10 | Sep 26, 2000 | Substantially Equivalent |
| K983119 | ENTERO-TEST HP, MODEL #102-01 | Mar 15, 1999 | Substantially Equivalent |