ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBE

Tubes, Gastrointestinal (and Accessories)

XERIDIEM MEDICAL DEVICES

The following data is part of a premarket notification filed by Xeridiem Medical Devices with the FDA for Entuit Thrive Lp Balloon Retention Gastrostomy Feeding Tube.

Pre-market Notification Details

• Device ID: K130674
• 510k Number: K130674
• Device Name: ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBE
• Classification: Tubes, Gastrointestinal (and Accessories)
• Applicant: XERIDIEM MEDICAL DEVICES 4700 S Overland Dr Tucson, AZ 85714
• Contact: Michelle Lott
• Correspondent: Michelle Lott; XERIDIEM MEDICAL DEVICES 4700 S Overland Dr Tucson, AZ 85714
• Product Code: KNT
• CFR Regulation Number: 876.5980 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-03-13
• Decision Date: 2014-01-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00827002356214	K130674	000
00827002356511	K130674	000
00827002356528	K130674	000
00827002356535	K130674	000
00827002356542	K130674	000
00827002356559	K130674	000
00827002356566	K130674	000
00827002356573	K130674	000
00827002356580	K130674	000
00827002356597	K130674	000
00827002356603	K130674	000
00827002356610	K130674	000
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00827002356634	K130674	000
00827002356641	K130674	000
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00827002356498	K130674	000
00827002356221	K130674	000
00827002356368	K130674	000
00827002356375	K130674	000
00827002356382	K130674	000
00827002356399	K130674	000
00827002356405	K130674	000
00827002356412	K130674	000
00827002356429	K130674	000
00827002356436	K130674	000
00827002356443	K130674	000
00827002356450	K130674	000
00827002356467	K130674	000
00827002356474	K130674	000
00827002356481	K130674	000
00827002356658	K130674	000
00827002356665	K130674	000
00827002356849	K130674	000
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00827002356863	K130674	000
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00827002356887	K130674	000
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00827002356900	K130674	000
00827002356917	K130674	000
00827002356924	K130674	000
00827002356931	K130674	000
00827002356948	K130674	000
00827002356955	K130674	000
00827002356962	K130674	000
00827002356979	K130674	000
00827002356825	K130674	000
00827002356818	K130674	000
00827002356672	K130674	000
00827002356689	K130674	000
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00827002356702	K130674	000
00827002356719	K130674	000
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00827002356757	K130674	000
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00827002356795	K130674	000
00827002356801	K130674	000
00827002356986	K130674	000