Safelock Disposable Blood Collection Set, Disposable Blood Collection Set

Set, Administration, Intravascular

JIANGYIN CAINA TECHNOLOGY CO., LTD.

The following data is part of a premarket notification filed by Jiangyin Caina Technology Co., Ltd. with the FDA for Safelock Disposable Blood Collection Set, Disposable Blood Collection Set.

Pre-market Notification Details

• Device ID: K151991
• 510k Number: K151991
• Device Name: Safelock Disposable Blood Collection Set, Disposable Blood Collection Set
• Classification: Set, Administration, Intravascular
• Applicant: JIANGYIN CAINA TECHNOLOGY CO., LTD. NO.2, TAIFU ROAD, HUASHI TOWN Jiangyin, CN 214421
• Contact: Jun Lu
• Correspondent: Diana Hong; MID-LINK CONSULTING CO., LTD P.O. BOX 120-119 Shanghai, CN 200120
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-07-20
• Decision Date: 2015-12-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20197344112040	K151991	000
00810008211908	K151991	000
00810008212578	K151991	000
00810008212608	K151991	000
00810008212639	K151991	000
00810008212660	K151991	000
16971564465912	K151991	000
16971564465998	K151991	000
16971564466001	K151991	000
16971564466018	K151991	000
00810008211878	K151991	000
20197344112156	K151991	000
20197344112149	K151991	000
20197344112057	K151991	000
30197344112061	K151991	000
30197344112078	K151991	000
30197344112085	K151991	000
20197344112095	K151991	000
20197344112101	K151991	000
30197344112115	K151991	000
30197344112122	K151991	000
30197344112139	K151991	000
16971564466032	K151991	000
16971564466049	K151991	000
16971564465929	K151991	000
30193489010422	K151991	000
00616784894010	K151991	000
00616784894119	K151991	000
00616784894218	K151991	000
00616784894331	K151991	000
00616784894430	K151991	000
00616784894539	K151991	000
00616784895024	K151991	000
00616784895123	K151991	000
20193489013136	K151991	000
20193489010456	K151991	000
20193489010418	K151991	000
16971564465936	K151991	000
30193489010408	K151991	000
30193489013119	K151991	000
20193489013129	K151991	000
30888277680238	K151991	000
20888277680224	K151991	000
30888277680245	K151991	000
10193489010411	K151991	000
20193489010432	K151991	000
00616784895222	K151991	000