HYPERBARIC PENETRATION EXTENSION SET— 510(k) K861315

Substantially Equivalent

Cutter Laboratories, Inc.

FDA 510(k) clearance K861315 for HYPERBARIC PENETRATION EXTENSION SET, Substantially Equivalent on 1986-05-21. Applicant: Cutter Laboratories, Inc..

Clearance details

Applicant: Cutter Laboratories, Inc.
Product code: Code CBF
Advisory panel: Anesthesiology
Date received: 1986-04-08
Decision date: 1986-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berkeley, CA, US

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Adverse events under product code CBF

product code CBF

Death: 6
Total: 6

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.