PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY)— 510(k) K081904
Substantially EquivalentMedcomp
FDA 510(k) clearance K081904 for PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY), Substantially Equivalent on 2008-09-23. Applicant: Medcomp. Device class: 2.
Clearance details
- Applicant
- Medcomp
- Product code
- Code LJS
- Device class
- Class 2
- Regulation
- 21 CFR 880.5970
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Harleysville, PA, US
Recent devices under product code LJS
view all- K260929 — Neonav ECG Tip Location System
- K252373 — BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology +6 more
- K252792 — PM2 System with ECGuide Connector
- K243458 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301) +5 more
- K251212 — Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)
More clearances from Medcomp
view allAdverse events under product code LJS
product code LJS- Death
- 31
- Injury
- 2,791
- Malfunction
- 18,374
- Other
- 5
- Total
- 21,201
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K081904
K-number listed on FDA's recall record- Z-0937-2013 — Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter.
- Z-0898-2013 — REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081904.
Data sourced from openFDA. This site is unofficial and independent of the FDA.