PUNCTURE KIT, DISPOSALBE VEIN

Syringe, Piston

ARROW INTL., INC.

The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Puncture Kit, Disposalbe Vein.

Pre-market Notification Details

• Device ID: K781978
• 510k Number: K781978
• Device Name: PUNCTURE KIT, DISPOSALBE VEIN
• Classification: Syringe, Piston
• Applicant: ARROW INTL., INC. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: FMF
• CFR Regulation Number: 880.5860 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1978-11-27
• Decision Date: 1978-12-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20801902185086	K781978	000
40801902122672	K781978	000
40801902122719	K781978	000
40801902122740	K781978	000
40801902122771	K781978	000
40801902122788	K781978	000
20801902157922	K781978	000
20801902160441	K781978	000
20801902158240	K781978	000
20801902158981	K781978	000
30801902000706	K781978	000
20801902158974	K781978	000
20801902162933	K781978	000
20801902161622	K781978	000
40801902121217	K781978	000
40801902121224	K781978	000
40801902121590	K781978	000
20801902147060	K781978	000
40801902122665	K781978	000
40801902121637	K781978	000
40801902121620	K781978	000
20801902185109	K781978	000
20801902187943	K781978	000
20801902188148	K781978	000
20801902188773	K781978	000
20801902168447	K781978	000
20801902168454	K781978	000
20801902004929	K781978	000
20801902004943	K781978	000
20801902008248	K781978	000
40801902118781	K781978	000
40801902121118	K781978	000
40801902121149	K781978	000
40801902121156	K781978	000
40801902121194	K781978	000
40801902121200	K781978	000
40801902121583	K781978	000
40801902121606	K781978	000
20801902147190	K781978	000
20801902147206	K781978	000
30801902004940	K781978	000
30801902004964	K781978	000
30801902005022	K781978	000
30801902005077	K781978	000
30801902007712	K781978	000
30801902007729	K781978	000
30801902007736	K781978	000
30801902008245	K781978	000
30801902009556	K781978	000
30801902009846	K781978	000
30801902009938	K781978	000
30801902011214	K781978	000
30801902011238	K781978	000
30801902097997	K781978	000
30801902098000	K781978	000
30801902098031	K781978	000
30801902099113	K781978	000
30801902004926	K781978	000
30801902004919	K781978	000
30801902004902	K781978	000
20801902147763	K781978	000
20801902147794	K781978	000
20801902147831	K781978	000
20801902147855	K781978	000
20801902147886	K781978	000
20801902147916	K781978	000
20801902147992	K781978	000
20801902148005	K781978	000
20801902149941	K781978	000
20801902149972	K781978	000
30801902118784	K781978	000
30801902121623	K781978	000
20801902121602	K781978	000
30801902000799	K781978	000
30801902000805	K781978	000
30801902000874	K781978	000
30801902000904	K781978	000
30801902100543	K781978	000