L-CATH INTRAVENOUS PLACEMENT UNIT— 510(k) K801575
Substantially EquivalentLuther Medical Products, Inc.
FDA 510(k) clearance K801575 for L-CATH INTRAVENOUS PLACEMENT UNIT, Substantially Equivalent on 1980-08-20. Applicant: Luther Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Luther Medical Products, Inc.
- Product code
- Code FOZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5200
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code FOZ
view allMore clearances from Luther Medical Products, Inc.
view all- K982797 — BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB
- K980090 — ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM)
- K974543 — L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER
- K940198 — L-CATH CONNECTOR ASSEMBLY
- K942103 — L-CATH CATHETER SYSTEM - PORT L-CATH
Adverse events under product code FOZ
product code FOZ- Death
- 38
- Injury
- 2,290
- Malfunction
- 25,858
- Other
- 11
- Total
- 28,197
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.