← Product Code [DTL](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL) · K092563 # GATOR CLIPSEAL PLUG (K092563) _Vascular Solutions, Inc. · DTL · Nov 4, 2009 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL/K092563 ## Device Facts - **Applicant:** Vascular Solutions, Inc. - **Product Code:** [DTL](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL.md) - **Decision Date:** Nov 4, 2009 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.4290 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic ## Intended Use The Gator ClipSeal Plug is intended to be used with 12F to 24F introducer sheaths to maintain a hemostatic seal around 0.035" or 0.038" guidewires. ## Device Story Gator ClipSeal Plug is a flexible polymer plug designed to minimize blood loss during interventional procedures. Device functions by creating a hemostatic seal within 12F-24F introducer sheaths when a 0.035" or 0.038" guidewire is present. Used in clinical settings by healthcare professionals during procedures requiring large-bore access. By maintaining the seal around the guidewire, the device prevents excessive bleeding, thereby improving procedural safety and maintaining a clear field for the clinician. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Flexible polymer plug; compatible with 12F-24F introducer sheaths and 0.035"/0.038" guidewires. Mechanical sealing principle. ## Regulatory Identification A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. ## Predicate Devices - Guardian Hemostasis Valve ([K073620](/device/K073620.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}------------------------------------------------ K092563 ## 510(k) Summary Date Prepared: October 21, 2009 ## Submitter's Name / Contact Person Manufacturer Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369 USA Establishment Registration # 2134812 ### Contact Person NOV - 4 2009 Loucinda Bjorklund Sr. Regulatory Affairs Associate Tel: 763-656-4300; Fax: 763-656-4253 Email: Ibjorklund@vascularsolutions.com # General Information | Trade Name | Gator™ ClipSeal Plug | |---------------------|-------------------------------------------------------------------------------------| | Common / Usual Name | Hemostatic plug | | Classification Name | 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting
Class II | | Predicate Device | K073620 Guardian Hemostasis Valve (Zerusa Limited) | ### Device Description The Gator ClipSeal Plug (GATOR) is a flexible polymer plug used to seal against blood loss through the hemostatic valve of 12F - 24F introducer sheaths. The GATOR can be used with 0.035" or 0.038" guidewires. #### Intended Use / Indications The Gator ClipSeal Plug is intended to be used with 12F to 24F introducer sheaths to maintain a hemostatic seal around 0.035" or 0.038" guidewires. #### Substantial Equivalence and Summary of Studies The Gator ClipSeal Plug is substantially equivalent in intended use and indications to the predicate device. Technological differences in design and materials have been qualified through biomaterial assessments and verification testing, the results of which did not raise any new safety or performance questions. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the seal of the Department of Health and Human Services. The seal features an eagle with its wings spread, and the words "Department of Health & Human Services - USA" are written around the eagle. The image is in black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002 NOV - 4 2009 Vascular Solutions, Inc. Ms. Loucinda Bjorklund Sr. Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, MN 55369 Re: K092563 Vascular Solutions Gator ClipSeal Plug Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary Bypass adaptor, stopcock, manifold, or fitting Regulatory Class: Class II Product Code: DTL Dated: August 19, 2009 Received: August 20, 2009 Dear Ms. Bjorklund: 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 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. 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 {2}------------------------------------------------ Page 2 - Ms. Loucinda Bjorklund comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Duna R. Vudner Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known): K092563 Device Name: : Gator™ ClipSeal Plug Indications for Use: The Gator ClipSeal Plug is intended to be used with 12F to 24F introducer sheaths to maintain a hemostatic seal around 0.035" or 0.038" guidewires. Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter (21 CFR 801 S Over-The-Counter Use (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 (Posted November 13, 2003) una R. V. Unn Ivision Sign-Off) (Division Sign-off) Division of Cardiovascular Devices 510(k) Number Kog --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL/K092563](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTL/K092563) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com