NAMIC PTCA Y-ADAPTOR— 510(k) K900652

Name: FDA 510(k) clearance K900652
Creator: U.S. Food and Drug Administration
Published: 1990-06-26

Substantially Equivalent

North American Instrument Corp.

FDA 510(k) clearance K900652 for NAMIC PTCA Y-ADAPTOR, Substantially Equivalent on 1990-06-26. Applicant: North American Instrument Corp.. Device class: 2.

Clearance details

Applicant: North American Instrument Corp.
Product code: Code DTL
Device class: Class 2
Regulation: 21 CFR 870.4290
Advisory panel: Cardiovascular
Date received: 1990-02-09
Decision date: 1990-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glens Falls, NY, 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 North American Instrument Corp.

view all

K960801 — SELECTOR ANGIOGRAPHIC CATHETER (VARIOUS MODELS)1996-03-29
K955554 — HEMO-VALVE1996-03-04
K960310 — EPIC INTRODUCER SHEATH1996-02-07
K922552 — MORSE(R) ANGIOGRAPHIC CATHETERS1993-03-03
K915078 — MORSE HEMOSTATIC CATHETER INTRODUCER SET1992-06-10

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.