CARDIOTOMY RESERVOIR CR-2000— 510(k) K790116

Name: FDA 510(k) clearance K790116
Creator: U.S. Food and Drug Administration
Published: 1979-02-08

Substantially Equivalent

Delta Medical Industries

FDA 510(k) clearance K790116 for CARDIOTOMY RESERVOIR CR-2000, Substantially Equivalent on 1979-02-08. Applicant: Delta Medical Industries. Device class: 3.

Clearance details

Applicant: Delta Medical Industries
Product code: Code DTB
Device class: Class 3
Regulation: 21 CFR 870.3680
Advisory panel: Cardiovascular
Date received: 1979-01-22
Decision date: 1979-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DTB

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K061212 — BIOTRONIK ENDOCARDIAL PACING LEADS2006-07-10
K041809 — PERMANENT PACING LEAD, MODEL PY22004-08-06
K040569 — PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU2004-04-07
K031274 — MODEL 5071 MYOCARDIAL PACING LEAD2003-05-22
K031210 — MODEL 4951M MYOCARDIAL UNIPOLAR LEAD2003-05-16

More clearances from Delta Medical Industries

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K833884 — ISOTEC DISPOS. PRESSURE TRANSDUCER1984-04-17
K840253 — ONE-WAY AIR VALVE1984-04-05
K832470 — INFUSION PUMP1984-02-28
K830389 — ACCU-RYNGE PUMP SP-2501983-09-12
K831750 — PM-31983-07-26

Adverse events under product code DTB

product code DTB

Death: 1,491
Injury: 67,311
Malfunction: 79,368
Other: 10
Total: 148,180

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.