REPROCESSED ELECTROPHYSIOLOGY CATHETER

Catheter, Recording, Electrode, Reprocessed

ALLIANCE MEDICAL CORP.

The following data is part of a premarket notification filed by Alliance Medical Corp. with the FDA for Reprocessed Electrophysiology Catheter.

Pre-market Notification Details

• Device ID: K030026
• 510k Number: K030026
• Device Name: REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Classification: Catheter, Recording, Electrode, Reprocessed
• Applicant: ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST. Phoenix, AZ 85044
• Contact: Moira Barton
• Correspondent: Moira Barton; ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST. Phoenix, AZ 85044
• Product Code: NLH
• CFR Regulation Number: 870.1220 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-01-03
• Decision Date: 2003-05-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00885825006099	K030026	000
00885825005979	K030026	000
00885825005962	K030026	000
00885825005955	K030026	000
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00885825006044	K030026	000
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00885825006020	K030026	000
00885825006013	K030026	000
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00885825005771	K030026	000
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00885825005825	K030026	000
00885825005818	K030026	000
00885825005801	K030026	000
00885825005689	K030026	000
00885825006518	K030026	000
00885825006396	K030026	000
00885825006389	K030026	000
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00885825006105	K030026	000