DISPOSABLE PARALLEL Y CONNECTORS— 510(k) K801404

Clearance details

Applicant

Texas Medical Products, Inc.

Product code

Code DTL

Device class

Class 2

Regulation

21 CFR 870.4290

Advisory panel

Cardiovascular

Date received

1980-06-13

Decision date

1980-06-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Walker, MI, US

• 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

• K893417 — SURGIFRESH SUB-MICRON MASK NO. 901008-0001989-06-22
• K870932 — SURGIFRESH SURGICAL SMOKE REMOVAL1987-03-31
• K851575 — DR. BRUNO LNAGE MINI PHOTOMETER1985-10-18
• K830634 — CARDIOTOMY FILTER1983-06-30
• K813587 — DISPOSABLE THORACIC CATHETER1982-01-12

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 →

• Z-0178-2015 — Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424 STERILE Expiration May 2019 Manufacturing Date May 2014Class II·Terminated·Dokitz NovoSci·20140918

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K801404.