CATHETER INTRODUCER— 510(k) K924562
Substantially EquivalentLuther Medical Products, Inc.
FDA 510(k) clearance K924562 for CATHETER INTRODUCER, Substantially Equivalent on 1993-02-25. Applicant: Luther Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Luther Medical Products, Inc.
- Product code
- Code DYB
- Device class
- Class 2
- Regulation
- 21 CFR 870.1340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tustin, CA, US
Recent devices under product code DYB
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 DYB
product code DYB- Death
- 808
- Injury
- 5,922
- Malfunction
- 16,516
- Other
- 5
- Total
- 23,251
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.