CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPH

Catheter, Flow Directed

ARROW INTL., INC.

The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Catheters For Balloon Occlusion Femoral Angiograph.

Pre-market Notification Details

• Device ID: K892530
• 510k Number: K892530
• Device Name: CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPH
• Classification: Catheter, Flow Directed
• Applicant: ARROW INTL., INC. P.O. BOX 6306 HILL AND GEORGE AVENUES Reading, PA 19610
• Contact: Thomas Nickel
• Correspondent: Thomas Nickel; ARROW INTL., INC. P.O. BOX 6306 HILL AND GEORGE AVENUES Reading, PA 19610
• Product Code: DYG
• CFR Regulation Number: 870.1240 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1989-04-11
• Decision Date: 1989-09-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20801902161356	K892530	000
20801902180258	K892530	000
20801902180234	K892530	000
20801902180821	K892530	000
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20801902161332	K892530	000
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20801902206651	K892530	000
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20801902180814	K892530	000
20801902180296	K892530	000
20801902180265	K892530	000
20801902180302	K892530	000
20801902180371	K892530	000
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20801902180357	K892530	000
20801902180333	K892530	000
20801902206330	K892530	000
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40801902004367	K892530	000
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60801902004347	K892530	000
40801902002905	K892530	000
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60801902002886	K892530	000
60801902002244	K892530	000
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00801902002303	K892530	000
20801902161325	K892530	000