INTERPLEURAL ANESTHESIA KIT W/POLYURETHANE CATH.— 510(k) K891281
Substantially EquivalentArrow Intl., Inc.
FDA 510(k) clearance K891281 for INTERPLEURAL ANESTHESIA KIT W/POLYURETHANE CATH., Substantially Equivalent on 1989-07-14. Applicant: Arrow Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Arrow Intl., Inc.
- Product code
- Product code CAZ
- Device class
- Class 2
- Regulation
- 21 CFR 868.5140
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Reading, PA, US
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- K071111 — NON-ABSORBABLE SILK SUTURE
Adverse events under product code CAZ
product code CAZ- Injury
- 145
- Malfunction
- 942
- Other
- 1
- Total
- 1,088
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.