DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR— 510(k) K071049
Substantially EquivalentTyco Healthcare
FDA 510(k) clearance K071049 for DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR, Substantially Equivalent on 2007-10-16. Applicant: Tyco Healthcare. Device class: 2.
Clearance details
- Applicant
- Tyco Healthcare
- Product code
- Code EZL
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
Recent devices under product code EZL
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- K061492 — MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE
- K042709 — DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER
- K040897 — DOVER ROB-NEL CATHETER
Adverse events under product code EZL
product code EZL- Death
- 6
- Injury
- 796
- Malfunction
- 4,989
- Other
- 1
- Total
- 5,792
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.