Spectranetics Corporation

Form 483

Colorado Springs, Colorado, United StatesFEI 3007284006Issued September 27, 2017

View FDA's Record for This Firm

Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3007284006.

Observations4

Issue DateSeptember 27, 2017

StatusNo Warning Letter

Related Inspections7

Establishment Details

Firm: Spectranetics Corporation
Location: Colorado Springs, Colorado, United States
FEI Number: 3007284006
Product Type: Devices
Issue Date: September 27, 2017
Country: United States

Inspection History, 2009 to 2019

NAI4

VAI2

OAI1

NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.

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Spectranetics Corporation FDA Form 483, Colorado Springs, Colorado, September 27, 2017