EMERSON TRO/CATH TROCAR CATHETERS— 510(k) K853132

Name: FDA 510(k) clearance K853132
Creator: U.S. Food and Drug Administration
Published: 1986-01-08

Substantially Equivalent

J. H. Emerson Co.

FDA 510(k) clearance K853132 for EMERSON TRO/CATH TROCAR CATHETERS, Substantially Equivalent on 1986-01-08. Applicant: J. H. Emerson Co.. Device class: 2.

Clearance details

Applicant: J. H. Emerson Co.
Product code: Code DRC
Device class: Class 2
Regulation: 21 CFR 870.1390
Advisory panel: Cardiovascular
Date received: 1985-07-26
Decision date: 1986-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from J. H. Emerson Co.

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K002598 — EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING2000-11-22
K920910 — OXYGEN POWERED RESUSCITATOR FOR CPR1993-01-12
K924174 — EMERSON IN-EXSUFFLATOR, MODELS 2-CM & 2-CA1992-11-17
K902764 — EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM1990-11-19
K896721 — MODEL 7-AT TREATMENT CHAMBER1990-01-22

Adverse events under product code DRC

product code DRC

Death: 28
Injury: 412
Total: 440

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.