510(k) K242969

Device: Pantera Pro; Pantera LEO
Applicant: Biotronik, Inc.
510(k) number: K242969
Product code: LOX
Decision: Substantially Equivalent (SESE)
Decision date: 2024-10-25
Date received: 2024-09-26
Regulation: 870.5100
Classification name: Catheters, Transluminal Coronary Angioplasty, Percutaneous
Medical specialty: Cardiovascular
Review panel: Cardiovascular
Device class: 2
Clearance type: Special
Statement or summary: Summary
Third party reviewed: No

Related Records

Applicant Contact

Contact: Jon Brumbaugh
Address: 6024 Jean Rd. Lake Oswego OR US 97035 97035

FDA Registration Numbers

3008573567
3002807315
3012050423
1028232
9617601
2183744
3016678045
2134265
1721686
3030236028
3015002281
3014390222
1313046
3014656749
3010220595
3004091615
9614654
3013546453
3043534762
9612164
3015910259
3003775186
3012167431
3004824117
3010273872
3031550970
3008002401
3004415014
3006946276
9681834
3009018440
2124215
3009965866
3002807314
3024893679
3019807891
3012693555
3014222368
3009205152
3007836437
3034695832
1000121056
3006550224
2939561
3011564431
3015453963
3035111606
3006513822
3003084171
3030421123
2134812
8043892
3013152301
3009564766
2011171
3010131137
9710284
3013634084
3016761372
3011137372
3007156625
1319639
3013944123
3010391265
3017961114
2024168
3008824097
3010432890
9681260
8010026
3014461810
3008700817
3017262662
3009613036
1225687

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code LOX

510(k)	Device	Applicant	Decision date
K252116	Firefighter Pro PTCA Balloon Catheter	Shanghai MicroPort Medical (Group) Co., Ltd.	2026-04-07
K254022	FLASH Flex Aorto-Ostial Angioplasty System	Verge Medical, Inc.	2026-04-02
K252295	Ryurei	Terumo Corporation	2026-03-27
K251970	Sprinter Legend Rapid Exchange Balloon Dilatation Catheter	Medtronic, Ireland	2026-01-17
K233499	Sapphire NC ULTRA Coronary Dilatation Catheter	OrbusNeich Medical (Shenzhen) Co., Ltd.	2024-08-16
K233505	Sapphire ULTRA Coronary Dilatation Catheter	OrbusNeich Medical (Shenzhen) Co., Ltd.	2024-08-15
K233729	Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58	Vascular Solutions, LLC	2024-05-31
K223189	Firefighter NC Pro PTCA Balloon Catheter	Shanghai MicroPort Medical (Group) Co., Ltd.	2023-07-21
K230374	Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®)	Dongguan TT Medical, Inc.	2023-06-29
K230705	POT PTCA Balloon Dilatation Catheter	Brosmed Medical Co., Ltd.	2023-04-11
K223022	SC HONKYTONK PTCA Balloon Dilatation Catheter	Sino Medical Sciences Technology, Inc.	2023-02-15
K222538	NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter	Sino Medical Sciences Technology, Inc.	2022-12-21
K220634	NC TREK NEO Coronary Dilatation Catheter	Abbott Vascular	2022-06-30
K220629	Emerge Monorail PTCA Dilatation Catheter	Boston Scientific	2022-03-24
K212393	OPN NC PTCA Dilatation Catheter	Sis Medical AG	2022-03-14