INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM— 510(k) K922970

Substantially Equivalent

Intensive Technology, Inc.

FDA 510(k) clearance K922970 for INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM, Substantially Equivalent on 1993-01-13. Applicant: Intensive Technology, Inc..

Clearance details

Applicant: Intensive Technology, Inc.
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 1992-06-19
Decision date: 1993-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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Adverse events under product code MCW

product code MCW

Death: 38
Injury: 1,386
Malfunction: 2,676
Other: 2
Total: 4,102

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.