← Product Code [DQX](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX) · K971281 # RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE (K971281) _Medcomp · DQX · Oct 9, 1997 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K971281 ## Device Facts - **Applicant:** Medcomp - **Product Code:** [DQX](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX.md) - **Decision Date:** Oct 9, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1330 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for Use THE MEDCOMP RAULERSON® ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE IS DESIGNED FOR GUIDEWIRE INSERTION IN PREPARATION FOR CATHETER PLACEMENT. IT IS INSERTED PERCUTANEOUSLY. IT IS INTENDED TO BE INSERTED BY QUALIFIED, EXPERIENCED PHYSICIANS ONLY. THIS PRODUCT IS NOT MEANT TO BE USED FOR ANY PURPOSE OTHER THAN THAT WHICH IS INDICATED ABOVE. ## Device Story The Raulerson One-Step Guidewire Insertion Bulb Needle is a manual surgical instrument used to facilitate percutaneous guidewire insertion. It functions as a conduit for guidewire placement prior to catheterization. The device is operated by qualified physicians in clinical settings. It simplifies the insertion process by providing a bulb-integrated needle design, allowing for direct guidewire passage. This aids in efficient vascular access, reducing procedural steps and potential complications during catheter placement. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Manual surgical needle with integrated bulb for guidewire insertion. Percutaneous application. No electronic components, software, or energy sources. ## Regulatory Identification A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. ## Special Controls *Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. ## 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} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856 Ms. Jeanne M. Cush Regulatory Affairs Coordinator Medcomp 1499 Delp Drive Harleysville, Pennsylvania 19438 OCT - 9 1997 Re: K971281 Raulerson® One-Step Guidewire Insertion Bulb Needle Regulatory Class: II (two) Product Code: DQX Dated: July 15, 1997 Received: July 21, 1997 Dear Ms. Cush: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {1} This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Thomas J. Callahan, Ph.D. Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2} 510(k) Number (if known): K971281 Device Name: Indications For Use: THE MEDCOMP RAULERSON® ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE IS DESIGNED FOR GUIDEWIRE INSERTION IN PREPARATION FOR CATHETER PLACEMENT. IT IS INSERTED PERCUTANEOUSLY. IT IS INTENDED TO BE INSERTED BY QUALIFIED, EXPERIENCED PHYSICIANS ONLY. THIS PRODUCT IS NOT MEANT TO BE USED FOR ANY PURPOSE OTHER THAN THAT WHICH IS INDICATED ABOVE. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ![img-0.jpeg](img-0.jpeg) (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number K971281 OR Over-The-Counter Use (Optional Format 1-2-96) Prescription Use ☑ (Per 21 CFR 801.109) --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K971281](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K971281) **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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