PRESSURE INFUSOR— 510(k) K881977

Name: FDA 510(k) clearance K881977
Creator: U.S. Food and Drug Administration
Published: 1988-07-29

Substantially Equivalent

Primrose Medical, Inc.

FDA 510(k) clearance K881977 for PRESSURE INFUSOR, Substantially Equivalent on 1988-07-29. Applicant: Primrose Medical, Inc.. Device class: 1.

Clearance details

Applicant: Primrose Medical, Inc.
Product code: Code KZD
Device class: Class 1
Regulation: 21 CFR 880.5420
Advisory panel: General Hospital
Date received: 1988-05-11
Decision date: 1988-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Primrose Medical, Inc.

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K884711 — URETHRAL AND URETERAL BALLOON DILATATORS1989-09-29
K884713 — COLONIC BALLOON DIALATORS1989-09-29
K884714 — BILIARY DIALATOR1989-09-29
K884715 — ACHELASIA BALLOON DIALATOR1989-09-29
K884709 — ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)1989-09-08

Adverse events under product code KZD

product code KZD

Death: 4
Total: 4

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.