POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED)
FDA 510(k) clearance K070003 · decided 2007-05-15
Clearance details
- K-number
- K070003
- Device name
- POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED)
- Applicant
- Medcomp
- Decision
- Substantially Equivalent
- Date received
- 2007-01-03
- Decision date
- 2007-05-15
- Days to decision
- 132 days
- Clearance type
- Traditional
- Product code
- LJT
- Device class
- 2
- Regulation number
- 880.5965
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Harleysville, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R recall (Z-1868-2012) | Medical Components, Inc dba MedComp | 2012-06-26 |
| 8F Plastic Dignity Mid-Sized CT Port w/Silicone Filled Suture Holes and w/Attachable Chron recall (Z-1626-2012) | Medical Components, Inc dba MedComp | 2012-05-18 |
| medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low Profile CT Port with Pre-Attached Chronofle recall (Z-2235-2010) | Medical Components, Inc dba MedComp | 2010-08-17 |