FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPTIV ANTAGE DH POWER INJECTION SYSTEM
K Number: K042744
·
Decision Nov 30, 2004
Classifications
1
FEI Numbers
120
Registration Numbers
120
Same Product Code
204
Applicant Total
8
Review Days
57
Basic Information
- Device Name
- OPTIV ANTAGE DH POWER INJECTION SYSTEM
- K Number
- K042744
- 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
- October 4, 2004
- Decision Date
- November 30, 2004
- Product Code
- DXT
- 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 |
|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXT), ordered by most recent decision date.
Angiography Injector
FDA 510(k)
FDA Class 2
·Cardiovascular
Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)
FDA 510(k)
FDA Class 2
·Cardiovascular
Single-use Sterile High-pressure Angiographic Syringes and Accessories
FDA 510(k)
FDA Class 2
·Cardiovascular
Disposable High-pressure Extension Lines
FDA 510(k)
FDA Class 2
·Cardiovascular
High Pressure Tubing
FDA 510(k)
FDA Class 2
·Cardiovascular
Sterile High-pressure Angiographic Syringes for Single-use
FDA 510(k)
FDA Class 2
·Cardiovascular
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 |
| K063503 | OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION | Apr 27, 2007 | 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 |