← Product Code [DQY](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY) · K052236 # BARD ATLAS PTA BALLOON DILATATION CATHETER (K052236) _Bard Peripheral Vascular, Inc. · DQY · Aug 23, 2005 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K052236 ## Device Facts - **Applicant:** Bard Peripheral Vascular, Inc. - **Product Code:** [DQY](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY.md) - **Decision Date:** Aug 23, 2005 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 870.1250 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic ## Indications for Use The Atlas™ PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the iliac arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries. ## Device Story Coaxial lumen catheter with distal balloon; two radiopaque marker bands for positioning. Used for Percutaneous Transluminal Angioplasty (PTA) of iliac arteries and treatment of obstructive lesions in dialysis fistulae. One lumen for guidewire insertion; second lumen for balloon inflation/deflation. Operated by clinicians in clinical settings. Device expands to treat vascular obstructions; benefits patient by restoring blood flow. Modification adds balloon sizes to existing predicate design. ## Clinical Evidence Bench testing only. Device met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, and test protocols. ## Technological Characteristics Coaxial lumen catheter; balloon mounted on distal tip; two radiopaque marker bands. Sterilization method consistent with predicate. No specific materials or software algorithms described. ## Regulatory 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 - Atlas™ PTA Balloon Dilatation Catheter ([K040243](/device/K040243.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ AUG 2 3 2005 ## Atlas™ PTA Balloon Dilatation Catheter 510(k) Summary of Safety and Effectiveness 21 CFR 807.92. As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a summary of the safety and effectiveness information upon which substantial equivalence determination is based as follows: - 1. Submitter Information: - Bard Peripheral Vascular, Inc Applicant: 1625 West 3rd Street P.O. Box 1740 Tempe, Arizona 85280 480-303-2524 Phone: 480-449-2546 Fax: Genevieve Balutowski, Regulatory Affairs Specialist Contact: ## 2. Subject Device Name: - Atlas™ PTA Balloon Device Trade Name: Dilatation Catheter Common or Usual Name: Percutaneous catheter Class II Classification: - Cardiovascular Classification Panel: ## Predicate Device: 3. Atlas™ PTA Balloon Dilatation Catheter (K040243, cleared 02/13/04) Image /page/0/Picture/14 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a distinct and modern appearance. The overall design is simple yet impactful, making the word easily recognizable. {1}------------------------------------------------ #### Summary of Change: 4. The design modification to the Atlas™ PTA Balloon Dilatation Catheter as represented in this submission is additional balloon sizes. All other aspects of the subject device remain the same as the predicate device. #### Device Description: 5. The Atlas™ PTA Balloon Dilatation Catheter is a coaxial lumen catheter with a balloon mounted on its distal tip. One lumen accommodates the insertion guidewire and the second provides a channel for inflation/deflation of the balloon. There are two radiopaque marker bands placed beneath the balloon to indicate its position within the vasculature. #### Intended Use of Device: ર. The Atlas™ PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the iliac arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries. ## Technological Comparison to Predicate Device: 7. The technological characteristics of Atlas™ PTA Balloon Dilatation Catheter are substantially equivalent to those of the predicate device, the Atlas™ PTA Balloon Dilatation Catheter, in terms of intended use, indication for use, application, user population, basic design, performance, and sterilization method. #### Conclusions: 8. The Atlas™ PTA Balloon Dilatation Catheter met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The Atlas™ PTA Balloon Dilatation Catheter is substantially equivalent to the legally marketed predicate device, the Atlas™ PTA Balloon Dilatation Catheter. Image /page/1/Picture/14 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a hollow appearance. The font is uniform in size and spacing, creating a balanced and legible design. {2}------------------------------------------------ Image /page/2/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be a caduceus, a symbol often associated with healthcare, featuring a staff entwined with snakes. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 2 3 2005 Bard Peripheral Vascular, Inc. c/o Ms. Genevieve Balutowski 1625 West 3rd Street P.O. Box 1740 Tempe, AZ 85280-1740 Re: K052236 Bard® Atlas™ PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 16, 2005 Received: August 17, 2005 Dear Ms. Balutowski: We have reviewed your Section 510(k) premarket notification of intent to market the device indicati we nave reviewed your becaon 310(x) premised is substantially equivalent (for the indications felerenced above and nave decembined by marketed predicate devices marketed in interstate for use stated in the encrosule) to regard chances of the Medical Device Amendments, or to commence prior to May 20, 1978, the encordance with the provisions of the Federal Food. Drug, devices that have been receasined in asset approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approval of a premarket approval app allu Cosmetic Act (11ct) market the device, subject to the general controls provisions of the Act. The I ou may, utcrefore, market the act include requirements for annual registration, listing of general controls provisions of wactice, 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 If your device is classified (500 above) this Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ourcements concerning your device in the Federal Register. {3}------------------------------------------------ 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 (QS) 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, suma R. Vochines er R. Vocus Center for Devices and Radiological Health Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): Kos 223 & Device Name: Atlas™ PTA Balloon Dilatation Catheter Indications for Use: The Atlas™ PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the iliac arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries. Prescription Use × (Part21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) . DIAMS & Concertify Conce of Device Evaluation (ODE) Concession Concerner Comment ்பாங்கா Sigm-Off) ്‍വേടിന് വ് Cardiovascular Devices Page 1 of 1 Number K052236 Bard Peripheral Vascular, Inc TRADE SECRET/CONFIDENTIAL INFORMATION Notify CR Bard Before Releasing this Document. BARD --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K052236](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K052236) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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