Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart F — Cardiovascular Therapeutic Devices](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices) → [21 CFR 870.5100](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5100) → LOX — Catheters, Transluminal Coronary Angioplasty, Percutaneous # LOX · Catheters, Transluminal Coronary Angioplasty, Percutaneous _Cardiovascular · 21 CFR 870.5100 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/LOX ## Overview - **Product Code:** LOX - **Device Name:** Catheters, Transluminal Coronary Angioplasty, Percutaneous - **Regulation:** [21 CFR 870.5100](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5100) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) ## Identification Standard PTCA Catheter: A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion. Cutting/scoring PTCA Catheter: A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis. ## Classification Rationale Standard PTCA Catheter: Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document. Cutting/scoring PTCA Catheter: Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3. ## Special Controls *Classification.* Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b) *Cutting/scoring PTCA Catheter* —(1)*Identification.* A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2) *Classification.* Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3. ## Recent Cleared Devices (20 of 106) Showing 20 most recent of 106 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252116](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/LOX/K252116.md) | Firefighter™ Pro PTCA Balloon Catheter | Shanghai MicroPort Medical (Group) Co., Ltd. | Apr 7, 2026 | SESE | | [K254022](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/LOX/K254022.md) | FLASH Flex™ Aorto-Ostial Angioplasty System | Verge Medical, Inc. | Apr 2, 2026 | SESE | | [K252295](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/LOX/K252295.md) | Ryurei | Terumo Corporation | Mar 27, 2026 | SESE | | [K251970](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/LOX/K251970.md) | Sprinter Legend Rapid Exchange Balloon Dilatation Catheter | Medtronic, Ireland | Jan 17, 2026 | SESE | | [K242969](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/LOX/K242969.md) | Pantera Pro; Pantera LEO | Biotronik, Inc. | Oct 25, 2024 | SESE | | [K233499](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/LOX/K233499.md) | Sapphire NC ULTRA Coronary Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | Aug 16, 2024 | SESE | | [K233505](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/LOX/K233505.md) | Sapphire ULTRA Coronary Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | Aug 15, 2024 | SESE | | [K233729](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/LOX/K233729.md) | 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 | May 31, 2024 | SESE | | [K223189](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/LOX/K223189.md) | Firefighter™ NC Pro PTCA Balloon Catheter | Shanghai MicroPort Medical (Group) Co., Ltd. | Jul 21, 2023 | SESE | | [K230374](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/LOX/K230374.md) | Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®) | Dongguan TT Medical, Inc. | Jun 29, 2023 | SESE | | [K230705](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/LOX/K230705.md) | POT PTCA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | Apr 11, 2023 | SESE | | [K223022](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/LOX/K223022.md) | SC HONKYTONK PTCA Balloon Dilatation Catheter | Sino Medical Sciences Technology, Inc. | Feb 15, 2023 | SESE | | [K222538](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/LOX/K222538.md) | NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter | Sino Medical Sciences Technology, Inc. | Dec 21, 2022 | SESE | | [K220634](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/LOX/K220634.md) | NC TREK NEO Coronary Dilatation Catheter | Abbott Vascular | Jun 30, 2022 | SESE | | [K220629](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/LOX/K220629.md) | Emerge Monorail PTCA Dilatation Catheter | Boston Scientific | Mar 24, 2022 | SESE | | [K212393](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/LOX/K212393.md) | OPN NC PTCA Dilatation Catheter | Sis Medical AG | Mar 14, 2022 | SESE | | [K211349](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/LOX/K211349.md) | Selebrek PTCA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | Jan 7, 2022 | SESE | | [K211807](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/LOX/K211807.md) | Sapphire NC 24 | OrbusNeich Medical (Shenzhen) Co., Ltd. | Oct 14, 2021 | SESE | | [K210012](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/LOX/K210012.md) | Tamarin Blue PTCA RX Dilatation Catheter | Natec Medical , Ltd. | Jul 9, 2021 | SESE | | [K211393](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/LOX/K211393.md) | Selethru(TM) NC PTCA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | Jul 2, 2021 | SESE | ## Top Applicants - Abbott Vascular — 6 clearances - Boston Scientific Corp — 6 clearances - Boston Scientific Corporation — 6 clearances - Ostial Corporation — 5 clearances - Orbusneich Medical Trading, Inc. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/LOX](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/LOX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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