PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY)
FDA 510(k) clearance K081904 · decided 2008-09-23
Clearance details
- K-number
- K081904
- Device name
- PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY)
- Applicant
- Medcomp
- Decision
- Substantially Equivalent
- Date received
- 2008-07-03
- Decision date
- 2008-09-23
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- LJS
- Device class
- 2
- Regulation number
- 880.5970
- 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
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 |
|---|---|---|
| Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen recall (Z-0937-2013) | Vygon Corporation | 2013-03-11 |
| REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injec recall (Z-0898-2013) | Medical Components, Inc dba MedComp | 2013-02-28 |