510(k) K030114

VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS by Vanguard Medical Concepts, Inc. — Product Code NLH

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 21, 2003
Date Received: January 13, 2003
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Catheter, Recording, Electrode, Reprocessed
Device Class: Class II
Regulation Number: 870.1220
Review Panel: CV
Submission Type

Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Other clearances by Vanguard Medical Concepts, Inc.

K053051 — VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES (December 22, 2005)
K051616 — VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES (September 6, 2005)
K051180 — VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES (July 22, 2005)
K051043 — VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (June 6, 2005)
K050763 — VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (June 1, 2005)
K043198 — VANGUARD REPROCESSED ARTHROSCOPIC WANDS (May 27, 2005)
K043253 — VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS (April 8, 2005)
K043594 — VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES (March 31, 2005)
K043225 — VANGUARD REPROCESSED ULTRASONIC SCALPEL (March 22, 2005)
K043315 — VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL (March 22, 2005)

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K233825 — Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter (June 7, 2024)
K221067 — Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiolog (May 31, 2023)
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