FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION
K Number: K063503
·
Decision Apr 27, 2007
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
21
Applicant Total
8
Review Days
158
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Basic Information
- Device Name
- OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION
- K Number
- K063503
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1650
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mallinckrodt Inc., Liebel-Flarsheim Business
- Date Received
- November 20, 2006
- Decision Date
- April 27, 2007
- Product Code
- IZQ
- 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 |
|---|---|---|---|
| IZQ | Injector, Contrast Medium, Automatic | FDA class 2 | Cardiovascular |
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ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
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ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
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FDA Class 2
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Other Clearances by Mallinckrodt Inc., Liebel-Flarsheim Business
| K Number | Device Name | ||
|---|---|---|---|
| K082212 | SYRINGE WITH HANDI-FIL | Jan 22, 2009 | Substantially Equivalent |
| K073592 | OPTISTAR ELITE INJECTION SYSTEM | May 7, 2008 | Substantially Equivalent |
| K042744 | OPTIV ANTAGE DH POWER INJECTION SYSTEM | Nov 30, 2004 | Substantially Equivalent |
| K031339 | OPTIBOLUS | Jul 11, 2003 | Substantially Equivalent |
| K022116 | ELPH INJECTION SYSTEM | Jul 26, 2002 | Substantially Equivalent |
| K984088 | OPTISTAR MR INJECTOR SYSTEM | Dec 6, 1999 | Substantially Equivalent |
| K963071 | ANGIOMAT ILLUMENA | Sep 23, 1997 | Substantially Equivalent |