MEDCOMP GEN III POWER INJECTABLE PORT
FDA 510(k) clearance K132177 · decided 2013-12-12
Clearance details
- K-number
- K132177
- Device name
- MEDCOMP GEN III POWER INJECTABLE PORT
- Applicant
- Medcomp ( Medical Components)
- Decision
- Substantially Equivalent
- Date received
- 2013-07-15
- Decision date
- 2013-12-12
- Days to decision
- 150 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
+ Add to Predicate Builder ◉ Watch Medcomp ( Medical Components)
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Power Injectable CT Port insertion kits - Product Usage: is an implantable access device d recall (Z-1184-2021) | Medical Components, Inc dba MedComp | 2021-03-08 |
| 9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The CT Power Injec recall (Z-1536-2017) | Medical Components, Inc dba MedComp | 2017-03-08 |