FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS
K Number: K011831
·
Decision Jun 28, 2001
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
18
Applicant Total
5
Review Days
16
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Basic Information
- Device Name
- MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS
- K Number
- K011831
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.5050
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Denver Biomedical, Inc.
- Date Received
- June 12, 2001
- Decision Date
- June 28, 2001
- Product Code
- DWM
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| DWM | Apparatus, Suction, Patient Care | FDA class 2 | Cardiovascular |
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Other Clearances by Denver Biomedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K051711 | PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS | Nov 15, 2005 | Substantially Equivalent |
| K052436 | PLEURX PLEURAL CATHETER KIT, MODEL 50-7000 | Oct 6, 2005 | Substantially Equivalent |
| K012235 | DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER | Oct 4, 2001 | Substantially Equivalent |
| K011862 | DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT | Jul 12, 2001 | Substantially Equivalent |