USCI PRO FLO XT,SOFT TIP, AND XT SOFT TIP ANGIOGRAPHIC— 510(k) K960056
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K960056 for USCI PRO FLO XT,SOFT TIP, AND XT SOFT TIP ANGIOGRAPHIC, Substantially Equivalent on 1996-10-23. Applicant: C.R. Bard, Inc.. Device class: 2.
Clearance details
- Applicant
- C.R. Bard, Inc.
- Product code
- Code DQO
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Billerica, MA, US
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Adverse events under product code DQO
product code DQO- Death
- 35
- Injury
- 993
- Malfunction
- 1,772
- Other
- 5
- Total
- 2,805
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.