MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS

Graft, Vascular, Synthetic/biologic Composite

BOSTON SCIENTIFIC CORP.

The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Modification To Hemashield Platinum Woven/microvel Double Velour Vascular Grafts.

Pre-market Notification Details

• Device ID: K021213
• 510k Number: K021213
• Device Name: MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS
• Classification: Graft, Vascular, Synthetic/biologic Composite
• Applicant: BOSTON SCIENTIFIC CORP. One Boston Scientific Place Natick, MA 01760
• Contact: Jennifer Bolton
• Correspondent: Jennifer Bolton; BOSTON SCIENTIFIC CORP. One Boston Scientific Place Natick, MA 01760
• Product Code: MAL
• CFR Regulation Number: 870.3450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-04-17
• Decision Date: 2002-04-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00384401017301	K021213	000
00384401018230	K021213	000
00384401018223	K021213	000
00384401018216	K021213	000
00384401018209	K021213	000
00384401018193	K021213	000
00384401018186	K021213	000
00384401018179	K021213	000
00384401018162	K021213	000
00384401018247	K021213	000
00384401018254	K021213	000
00384401018339	K021213	000
00384401018322	K021213	000
00384401018315	K021213	000
00384401018308	K021213	000
00384401018292	K021213	000
00384401018285	K021213	000
00384401018278	K021213	000
00384401018261	K021213	000
00384401018155	K021213	000
00384401018148	K021213	000
00384401018032	K021213	000
00384401018025	K021213	000
00384401018018	K021213	000
00384401018001	K021213	000
00384401017998	K021213	000
00384401017332	K021213	000
00384401017325	K021213	000
00384401017318	K021213	000
00384401018049	K021213	000
00384401018056	K021213	000
00384401018131	K021213	000
00384401018124	K021213	000
00384401018117	K021213	000
00384401018100	K021213	000
00384401018094	K021213	000
00384401018087	K021213	000
00384401018070	K021213	000
00384401018063	K021213	000
00384401018346	K021213	000
00384401018353	K021213	000
00384401018636	K021213	000
00384401018629	K021213	000
00384401018612	K021213	000
00384401018605	K021213	000
00384401018599	K021213	000
00384401018582	K021213	000
00384401018575	K021213	000
00384401018568	K021213	000
00384401018643	K021213	000
00384401018650	K021213	000
00384401018742	K021213	000
00384401018735	K021213	000
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00384401018711	K021213	000
00384401018704	K021213	000
00384401018698	K021213	000
00384401018674	K021213	000
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00384401018551	K021213	000
00384401018544	K021213	000
00384401018438	K021213	000
00384401018421	K021213	000
00384401018414	K021213	000
00384401018407	K021213	000
00384401018391	K021213	000
00384401018384	K021213	000
00384401018377	K021213	000
00384401018360	K021213	000
00384401018445	K021213	000
00384401018452	K021213	000
00384401018537	K021213	000
00384401018520	K021213	000
00384401018513	K021213	000
00384401018506	K021213	000
00384401018490	K021213	000
00384401018483	K021213	000
00384401018476	K021213	000
00384401018469	K021213	000
00384401018759	K021213	000