PATIENT VALVE WITH AIR ENTRAINMENT— 510(k) K863410

Substantially Equivalent

Pneupac , Ltd.

FDA 510(k) clearance K863410 for PATIENT VALVE WITH AIR ENTRAINMENT, Substantially Equivalent on 1987-01-12. Applicant: Pneupac , Ltd..

Clearance details

Applicant: Pneupac , Ltd.
Product code: Code BTL
Advisory panel: Anesthesiology
Date received: 1986-07-23
Decision date: 1987-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Luton Beds Lu2 Oah, GB

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Adverse events under product code BTL

product code BTL

Death: 8
Malfunction: 3,256
Other: 1
Total: 3,265

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.