HARBOR S.E.A.-PORT SURGICAL ACCESSORY KIT— 510(k) K882657

Name: FDA 510(k) clearance K882657
Creator: U.S. Food and Drug Administration
Published: 1988-12-13

Substantially Equivalent

Harbor Medical Devices, Inc.

FDA 510(k) clearance K882657 for HARBOR S.E.A.-PORT SURGICAL ACCESSORY KIT, Substantially Equivalent on 1988-12-13. Applicant: Harbor Medical Devices, Inc.. Device class: 2.

Clearance details

Applicant: Harbor Medical Devices, Inc.
Product code: Code DYB
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 1988-06-29
Decision date: 1988-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Harbor Medical Devices, Inc.

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K884628 — HARBORIN CENTRAL VENOUS CATHETER1989-05-15
K890518 — SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM1989-04-21
K881884 — HARBOR CENTRAL VENOUS CATHETER1988-07-28
K882190 — S.E.A.-PORT(TM) VASCULAR ACCESS SYSTEM1988-06-09
K880297 — SEA - PORT INFUSION SET1988-02-19

Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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.