PLASTIC TUBING ADAPTERS 5-IN-1-— 510(k) K800880

Name: FDA 510(k) clearance K800880
Creator: U.S. Food and Drug Administration
Published: 1980-05-14

Substantially Equivalent

Harvard Laboratories

FDA 510(k) clearance K800880 for PLASTIC TUBING ADAPTERS 5-IN-1-, Substantially Equivalent on 1980-05-14. Applicant: Harvard Laboratories. Device class: 2.

Clearance details

Applicant: Harvard Laboratories
Product code: Code DTL
Device class: Class 2
Regulation: 21 CFR 870.4290
Advisory panel: Cardiovascular
Date received: 1980-04-17
Decision date: 1980-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DTL

view all

K152528 — Attachable Cath Lab Hemostasis Valve2015-12-02
K143429 — Passage Hemostasis Valve2014-12-22
K140475 — ROTATING ADAPTERS2014-04-16
K131124 — COLIGN2013-08-28
K123448 — AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE2012-12-13

More clearances from Harvard Laboratories

view all

K822765 — SIGMOIDOSCOPE, FLEXIBLE1982-11-17
K810573 — TUBE FEEDING SET1981-04-23
K810574 — SUCTION COLLECTION BOTTLE, DISPOSABLE1981-04-21
K800877 — ANESTHESIA EXTENSION TUBES1980-06-17
K800878 — SECONDARY I.V. TUBING SETS1980-06-17

Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

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.