SIGNATURE(TM) CUSTOM TUBING PACK

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

AVECOR CARDIOVASCULAR, INC.

The following data is part of a premarket notification filed by Avecor Cardiovascular, Inc. with the FDA for Signature(tm) Custom Tubing Pack.

Pre-market Notification Details

• Device ID: K924529
• 510k Number: K924529
• Device Name: SIGNATURE(TM) CUSTOM TUBING PACK
• Classification: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
• Applicant: AVECOR CARDIOVASCULAR, INC. 13010 COUNTRY RD. 6 Plymouth, MN 55441
• Contact: Dennis E Steger
• Correspondent: Dennis E Steger; AVECOR CARDIOVASCULAR, INC. 13010 COUNTRY RD. 6 Plymouth, MN 55441
• Product Code: DWF
• CFR Regulation Number: 870.4210 [🔎]
• Decision: Substantially Equivalent - Kit (SESK)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-09-08
• Decision Date: 1993-06-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20721902958797	K924529	000
20643169632619	K924529	000
20643169630714	K924529	000
20643169618361	K924529	000
20643169596621	K924529	000
20643169596607	K924529	000
20643169596584	K924529	000
20643169596560	K924529	000
20643169596546	K924529	000
20643169591343	K924529	000
20643169649815	K924529	000
20643169660452	K924529	000
20721902937990	K924529	000
20721902930496	K924529	000
20721902855379	K924529	000
20721902838464	K924529	000
20721902838433	K924529	000
20721902835821	K924529	000
20721902832509	K924529	000
20643169708130	K924529	000
20643169661060	K924529	000
20643169568369	K924529	000
20643169433179	K924529	000
20763000267043	K924529	000
20763000523644	K924529	000
20763000582979	K924529	000
20763000608877	K924529	000
20763000631615	K924529	000
20763000644301	K924529	000
20763000644271	K924529	000
00763000702144	K924529	000
20763000548715	K924529	000
20613994733690	K924529	000
20643169120185	K924529	000
20643169411344	K924529	000
20643169383887	K924529	000
20643169346318	K924529	000
20643169341856	K924529	000
20643169313754	K924529	000
20643169307760	K924529	000
20643169306961	K924529	000
20643169271627	K924529	000
20643169158324	K924529	000
20763000865386	K924529	000
20721902979617	K924529	000
20613994911524	K924529	000
20643169356393	K924529	000
20643169349425	K924529	000
20643169346332	K924529	000
20643169346325	K924529	000
20643169309689	K924529	000
20643169273386	K924529	000
20643169192731	K924529	000
20643169188239	K924529	000
20643169186983	K924529	000
20643169783311	K924529	000
20643169856596	K924529	000
20613994840183	K924529	000
20613994728566	K924529	000
20613994667773	K924529	000
20613994648314	K924529	000
20613994603610	K924529	000
20613994352549	K924529	000
20613994224297	K924529	000
20643169935840	K924529	000
20643169859382	K924529	000
00673978546407	K924529	000
00673978546391	K924529	000
20763000092416	K924529	000
20763000056630	K924529	000
20763000008332	K924529	000
20885074508188	K924529	000
20885074417756	K924529	000
20885074213013	K924529	000
20885074011787	K924529	000
20885074332578	K924529	000
20885074148339	K924529	000
20763000094137	K924529	000
20763000158129	K924529	000
00673978546384	K924529	000
00673978546377	K924529	000
00673978546360	K924529	000
00673978546353	K924529	000
20721902938003	K924529	000
20721902925683	K924529	000
20721902844342	K924529	000
20763000187921	K924529	000
20763000168456	K924529	000
20721902981290	K924529	000