DIAGNOSTIC CATHETER SYSTEM— 510(k) K091250
Substantially EquivalentCardinal Health, Inc.
FDA 510(k) clearance K091250 for DIAGNOSTIC CATHETER SYSTEM, Substantially Equivalent on 2009-05-22. Applicant: Cardinal Health, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardinal Health, Inc.
- Product code
- Code EOQ
- Device class
- Class 2
- Regulation
- 21 CFR 874.4680
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mcgaw Park, IL, US
Recent devices under product code EOQ
view allMore clearances from Cardinal Health, Inc.
view all- K170198 — Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White)
- K160411 — Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating
- K160875 — Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating
- K153316 — Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)
- K122696 — POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)
Adverse events under product code EOQ
product code EOQ- Death
- 135
- Injury
- 2,863
- Malfunction
- 21,662
- Total
- 24,660
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.