Who is the manufacturer of FOXCROSS PTA CATHETER?

Abbott Vascular, Inc. filed the 510(k) submission for FOXCROSS PTA CATHETER (K081417).

What is the FDA product code for FOXCROSS PTA CATHETER?

LIT. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for FOXCROSS PTA CATHETER?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like FOXCROSS PTA CATHETER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

FOXCROSS PTA CATHETER

K081417 · Abbott Vascular, Inc. · LIT · Jun 4, 2008 · Cardiovascular

Device Facts

Record ID	K081417
Device Name	FOXCROSS PTA CATHETER
Applicant	Abbott Vascular, Inc.
Product Code	LIT · Cardiovascular
Decision Date	Jun 4, 2008
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.1250
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The FoxCross PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistulae. This catheter is not intended for the expansion or delivery of stents.

Device Story

FoxCross PTA Catheter is a standard over-the-wire percutaneous transluminal angioplasty (PTA) catheter; features double-lumen design with distal balloon. One lumen facilitates balloon inflation; second lumen allows guide wire insertion (max 0.035"). Two radiopaque markers on balloon assist in positioning relative to stenosis. Operated by physicians in clinical settings for arterial and dialysis fistula lesion dilatation. Device expands to known diameter at specific pressures. Modifications from predicate include shaft/tip color, balloon coating, adhesive, and removal of strain relief shrink tubing.

Clinical Evidence

Bench testing only; no clinical data.

Technological Characteristics

Double-lumen over-the-wire PTA catheter; radiopaque markers for positioning; balloon material expands to specific diameters at defined pressures. Modifications include specific balloon coating and adhesive. No software or electronic components.

Indications for Use

Indicated for dilatation of lesions in femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistulae. Not for stent expansion or delivery.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

FoxPlus PTA Catheter

Related Devices

K090509 — FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342-20, FOXCROSS .035 PTA CATHETER · Abbott Vascular-Vascular Solutions · Mar 20, 2009
K080925 — FOX PLUS PTA CATHETER · Abbott Vascular, Inc. · Apr 28, 2008
K080264 — MODIFICATION TO: FOX PLUS PTA CATHETER · Abbott Vascular-Vascular Solutions · Mar 26, 2008
K040954 — FOX PLUS PTA CATHETER · Abbott Laboratories, Inc. · May 11, 2004
K062843 — FOX SV PTA CATHETER · Abbott Laboratories · Oct 17, 2006

Submission Summary (Full Text)

{0}------------------------------------------------ K081417 Page lot 1 ## Abbott Vascular FoxCross PTA Catheter Special 510(k) ## Appendix A – 510(k) SUMMARY The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.93UN ~ 4 2008 | | Submitter's Name: Submitter's Address: | Abbott Vascular 3200 Lakeside Drive Santa Clara, CA 95054 | |--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------| | | Telephone: Fax: | 951-914-2292 951-914-1069 | | | Contact Person: | Nadine Smith | | | Date Prepared: | May 19, 2005 | | | Device Trade Name: Device Common Name: Device Classification Name: | FoxCross PTA Catheter PTA Catheter Catheter | | | Device Classification No .: Device Classification: Device Product Code: | 21 CFR 870.1250 Class II LIT | | Device Description | The FoxCross PTA Catheter is a standard over-the-wire PTA catheter. The double lumen catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the second lumen allows access to the distal tip of the catheter for guide wire insertion (max 0.035"). The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The balloon material expands to a known diameter at specific pressures. | | | Intended Use | The intended use for the device has not changed as a result of the modification. The FoxCross PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistulae. This catheter is not intended for the expansion or delivery of stents. | | | Summary of Technological Characteristics Compared to Predicate Device | The FoxCross PTA Catheter, subject device, is identical in technological characteristics, to the FoxPlus PTA Catheter, predicate device, with respect to product code, classification section, classification name, intended use, catheter length, balloon diameters and lengths, introducer sheath size, and guide wire compatibility. | | | | Minor changes were to the FoxCross, including a different color for the shaft and tip, coating on the balloon, adhesive used, and removal of shrink tubing on the strain relief. | | | Summary of Substantial Equivalence | The FoxCross PTA Catheter, subject device, is substantially equivalent to the FoxPlus PTA Catheter, predicate device, as demonstrated by the results of the in vitro bench tests, analyses, and biocompatibility data. | | {1}------------------------------------------------ Public Health Service ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN - 4 2008 Abbott Vascular c/o Ms. Nadine Smith Regulatory Affairs 26531 Ynez Road Temecula, CA 92591 Re: K081417 FoxCross PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: LIT Dated: May 19, 2008 Received: May 20, 2008 Dear Ms. Smith: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {2}------------------------------------------------ ## Page 2 - Ms. Nadine Smith Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours. R. vodinel A. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Appendix A - Indications for Use K 381417 510(k) Number (if known) Device Name FoxCross PTA Catheter Indications for Use The FoxCross PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistula. This catheter is not intended for the expansion or delivery of stents. Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 Duna R. Vuhner vision Sign-Off) Ision of Cardiovascular Devices 01K) Number_K081417