FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RITA CLIPS FOR INFUSION PUMPS
K Number: K030936
·
Decision Apr 1, 2003
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
47
Applicant Total
9
Review Days
7
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Basic Information
- Device Name
- RITA CLIPS FOR INFUSION PUMPS
- K Number
- K030936
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rita Medical Systems, Inc.
- Date Received
- March 25, 2003
- Decision Date
- April 1, 2003
- Product Code
- MRZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MRZ | Accessories, Pump, Infusion | FDA class 2 | General Hospital |
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Other Clearances by Rita Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K070101 | UNIBLATE ELECTROSURGICAL DEVICE | Feb 14, 2007 | Substantially Equivalent |
| K062414 | VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET | Feb 1, 2007 | Substantially Equivalent |
| K062579 | OMNIPICC P.I. | Nov 28, 2006 | Substantially Equivalent |
| K051102 | OMNIPICC PI | Nov 23, 2005 | Substantially Equivalent |
| K050176 | VORTEX EZ VASCULAR ACCESS PORT | Feb 25, 2005 | Substantially Equivalent |
| K032149 | RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR | Sep 9, 2003 | Substantially Equivalent |
| K031926 | RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E.G., RITA THERMO PAD AND CABLE ADAPTER) | Jul 17, 2003 | Substantially Equivalent |
| K031257 | RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR | May 2, 2003 | Substantially Equivalent |