SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports

Port & Catheter, Implanted, Subcutaneous, Intravascular

AngioDynamics, Inc.

The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Smartport+ Implantable Ports, Smartport Plastic Implantable Ports.

Pre-market Notification Details

• Device ID: K190559
• 510k Number: K190559
• Device Name: SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports
• Classification: Port & Catheter, Implanted, Subcutaneous, Intravascular
• Applicant: AngioDynamics, Inc. 26 Forest Street Marlborough, MA 01752
• Contact: Vidyalakshmi Jayaraman
• Correspondent: Vidyalakshmi Jayaraman; AngioDynamics, Inc. 26 Forest Street Marlborough, MA 01752
• Product Code: LJT
• CFR Regulation Number: 880.5965 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-03-05
• Decision Date: 2020-05-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
H787CT80STBDNFVI0	K190559	000
H787CT80LPBDNFVI0	K190559	000
H787CT80LPBAVI0	K190559	000
H787CT80LPBANFVI0	K190559	000
H787CT60STBDVI0	K190559	000
H787CT60STBDNFVI0	K190559	000
H787CT60STBAVI0	K190559	000
H787CT60STBANFVI0	K190559	000
H787CT60PTBDVI0	K190559	000
H787CT60PTBDNFVI0	K190559	000
H787CT60PTBAVI0	K190559	000
H787CT60PTBANFVI0	K190559	000
H787CT60LTBDVI0	K190559	000
H787CT80LPBDVI0	K190559	000
H787CT80LPPANFNV0	K190559	000
H787CT80LPPANFVI0	K190559	000
H787CT80STBAVI0	K190559	000
H787CT80STBANFVI0	K190559	000
H787CT80LTBDVI0	K190559	000
H787CT80LTBDNFVI0	K190559	000
H787CT80LTBAVI0	K190559	000
H787CT80LTBANFVI0	K190559	000
H787CT80LPPDVI0	K190559	000
H787CT80LPPDNV0	K190559	000
H787CT80LPPDNFVI0	K190559	000
H787CT80LPPDNFNV0	K190559	000
H787CT80LPPAVI0	K190559	000
H787CT80LPPANV0	K190559	000
H787CT60LTBDNFVI0	K190559	000
H787CT60LTBAVI0	K190559	000
H787CT60LTBANFVI0	K190559	000
H787CT50PTBDNFVI0	K190559	000
H787CT50PTBAVI0	K190559	000
H787CT50PTBANFVI0	K190559	000
H787CT50LTBDVI0	K190559	000
H787CT50LTBDNFVI0	K190559	000
H787CT50LTBAVI0	K190559	000
H787CT50LTBANFVI0	K190559	000
H787CT50LPBDVI0	K190559	000
H787CT50LPBDNFVI0	K190559	000
H787CT50LPBAVI0	K190559	000
H787CT50LPBANFVI0	K190559	000
15051684016865	K190559	000
H787CT50PTBDVI0	K190559	000
H787CT50STBDNFVI0	K190559	000
H787CT50STBDVI0	K190559	000
H787CT60LPPDVI0	K190559	000
H787CT60LPPDNV0	K190559	000
H787CT60LPPDNFVI0	K190559	000
H787CT60LPPDNFNV0	K190559	000
H787CT60LPPAVI0	K190559	000
H787CT60LPPANV0	K190559	000
H787CT60LPPANFVI0	K190559	000
H787CT60LPPANFNV0	K190559	000
H787CT60LPBDVI0	K190559	000
H787CT60LPBDNFVI0	K190559	000
H787CT60LPBAVI0	K190559	000
H787CT60LPBANFVI0	K190559	000
15051684016858	K190559	000
H787CT80STBDVI0	K190559	000
15051684016926	K190559	000
15051684016773	K190559	000
15051684017145	K190559	000
15051684016766	K190559	000
15051684017152	K190559	000
15051684016889	K190559	000
15051684016872	K190559	000
15051684016902	K190559	000
15051684016896	K190559	000
15051684016759	K190559	000
15051684017084	K190559	000
15051684016742	K190559	000
15051684017091	K190559	000
15051684017237	K190559	000
15051684017220	K190559	000
15051684016780	K190559	000
15051684016919	K190559	000
15051684016940	K190559	000
15051684016933	K190559	000
15051684017046	K190559	000
15051684017039	K190559	000
15051684016827	K190559	000
15051684017053	K190559	000
15051684016810	K190559	000
15051684016803	K190559	000
15051684017206	K190559	000
15051684017213	K190559	000
15051684016797	K190559	000
15051684017008	K190559	000
15051684016995	K190559	000
15051684017022	K190559	000
H787CT50STBAVI0	K190559	000
15051684016674	K190559	000
15051684017060	K190559	000
15051684016667	K190559	000
15051684017077	K190559	000
15051684016964	K190559	000
15051684016957	K190559	000
15051684016988	K190559	000
15051684016971	K190559	000
15051684016650	K190559	000
15051684017107	K190559	000
15051684016643	K190559	000
15051684016834	K190559	000
15051684016841	K190559	000
15051684017138	K190559	000
15051684017015	K190559	000
15051684016735	K190559	000
15051684016728	K190559	000
15051684017169	K190559	000
15051684017176	K190559	000
15051684016711	K190559	000
15051684016704	K190559	000
15051684017183	K190559	000
15051684017190	K190559	000
15051684016698	K190559	000
15051684017121	K190559	000
15051684016681	K190559	000
15051684017114	K190559	000