HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C— 510(k) K893439
Substantially EquivalentMedical Components, Inc.
FDA 510(k) clearance K893439 for HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C, Substantially Equivalent on 1989-06-13. Applicant: Medical Components, Inc.. Device class: 2.
Clearance details
- Applicant
- Medical Components, Inc.
- Product code
- Code LFJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Harleysville, PA, US
Recent devices under product code LFJ
view allMore clearances from Medical Components, Inc.
view allRecalls naming K893439
K-number listed on FDA's recall record- Z-1149-2019 — 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422
- Z-2215-2019 — 14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423 Product Usage: An aid for introducing a hemodialysis catheter
- Z-2216-2019 — 14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424 Product Usage: An aid for introducing a hemodialysis catheter
- Z-2217-2019 — 14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425 Product Usage: An aid for introducing a hemodialysis catheter
- Z-1083-2015 — Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 24CM LT HEMO-CATH), MC061422 (14FX15CM SLX DBL LMN ST CATH), MRCTP41017 (4F X 55CM SINGLE CT PICC), MRCTP52007 (5F DUAL PRO-PICC NURSING TRAY), MRCTP52010 (5F DUAL PRO-PICC MAX BARR TRAY), MR81013106MB (3FX60CM SGL TAPRLS VASCU-PICC). Intended uses: To attain long-term vascular access for hemodialysis and apheresis. The Medcomp SLX Silicone Double Lumen Catheter is designed for acute hemodialysis and apheresis. The Pro-PICC¿ CT catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media, and allows for central venous pressure monitoring. The Peripherally Inserted Central Vein Access Catheters are designed for Long or Short- Term peripheral access to the central venous system for intravenous therapy and blood sampling, and allows for central venous pressure monitoring.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K893439.
Data sourced from openFDA. This site is unofficial and independent of the FDA.