FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GESCO PER-Q-CATH MIDLINE CATHETERS
K Number: K971991
·
Decision Nov 7, 1997
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
21
Review Days
182
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Basic Information
- Device Name
- GESCO PER-Q-CATH MIDLINE CATHETERS
- K Number
- K971991
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bard Access Systems, Inc.
- Date Received
- May 9, 1997
- Decision Date
- November 7, 1997
- 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 |
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|---|---|---|---|
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| K071095 | ASPIRA PLEURAL DRAINAGE SYSTEM | May 18, 2007 | Substantially Equivalent |