IRRI-CATH— 510(k) K833908
Substantially EquivalentPortex, Inc.
FDA 510(k) clearance K833908 for IRRI-CATH, Substantially Equivalent on 1984-02-04. Applicant: Portex, Inc.. Device class: 1.
Clearance details
- Applicant
- Portex, Inc.
- Product code
- Code BSY
- Device class
- Class 1
- Regulation
- 21 CFR 868.6810
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code BSY
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view all- K033080 — PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER
- K031057 — PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT
- K023793 — 1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR
- K014115 — 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX
- K014073 — HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE
Adverse events under product code BSY
product code BSY- Death
- 3
- Injury
- 155
- Malfunction
- 959
- Total
- 1,117
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.