← Product Code [DXC](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXC) · K123077 # VASCULAR CLAMPS (K123077) _Hebumedical GmbH · DXC · May 14, 2013 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXC/K123077 ## Device Facts - **Applicant:** Hebumedical GmbH - **Product Code:** [DXC](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXC.md) - **Decision Date:** May 14, 2013 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.4450 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic ## Intended Use Vascular Clamps are indicated for use for temporary or partial occlusion of blood vessels during open surgical procedures. ## Device Story Reusable stainless steel ring-handled clamps; used for temporary or partial occlusion of blood vessels during open surgical procedures. Device features various shapes, sizes, and lengths to accommodate specific anatomy and occlusion types; includes ratchet closure to adjust tension applied to vessel. Operated by surgeons in clinical/surgical settings. Device provided non-sterile; requires user sterilization. Benefits include maintaining clear field of vision by keeping handles/shanks away from operative site and providing controlled vessel occlusion. ## Clinical Evidence Bench testing only. Testing assessed clamp force and occlusion capabilities to demonstrate performance equivalence to predicate devices. ## Technological Characteristics Reusable stainless steel construction; ring-handled design with ratchet lock mechanism. Multiple jaw tip configurations and lengths available. Non-sterile; requires user-performed sterilization. Mechanical operation via manual tension adjustment. ## Regulatory Identification A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily. ## Predicate Devices - Aesculap Vascular Instruments ([K992053](/device/K992053.md)) - Sibel Vascular Clamp ([K072834](/device/K072834.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}------------------------------------------------ ### 510(k) SUMMARY ## K123077 Date: September 27, 2012 Submitter: Name: HEBUmedical GmbH Address: Badstrasse 5 78532 Tuttlingen Germany Contact Thomas Butsch Person: Telephone: +49.7461.94710 +49.7461.947122 Fax: Product: Trade Name: Vascular Clamps Common Name: Vascular Clamp Classification Name: Vascular Clamp Predicate o K992053 - Aesculap Vascular Instruments Device: o K072834 - Sibel Vascular Clamp Device HEBUmedical Vascular Clamps are reusable stainless Description: steel ring-handled clamps provided in a wide variety of shapes, sizes and lengths to accommodate the individual needs of the surgeon and the procedure. based on the anatomy of the site and type of occlusion. The length and angles are design features that can be important to keep the handles and shanks out of the field of vision of the operative site. The handle is provided with a ratchet closure, which permits the surgeon to adjust the amount of tension applied to the vessel. The device is provided non-sterile for sterilization by the user. Indications for Vascular Clamps are indicated for use for temporary or partial occlusion of blood vessels during open surgical Use: procedures. Technological Bench testing was performed to assess clamp force and Characteristics occlusion. The device has similar technological and performance characteristics as the predicate devices, as shown by the following summary table: MAY 1 4 2013 {1}------------------------------------------------ | Manufacturer | HEBUmedical | Surgical
Instruments
Belgium | Aesculap | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Design | Multiple jaw tips
and orientation,
ratchet lock on
handle, ring
handle | Multiple jaw tips
and orientation,
ratchet lock on
handle, ring
handle | Multiple jaw tips
and orientation,
ratchet lock on
handle, ring
handle | | Principle of
Operation | Clamp jaw is
applied to the
vessel. The
amount of
tension applied
to the vessel for
occlusion or
partial occlusion
is adjusted by
means of the
ratchet closure | Clamp jaw is
applied to the
vessel. The
amount of tension
applied to the
vessel for
occlusion or
partial occlusion
is adjusted by
means of the
ratchet closure | Clamp jaw is
applied to the
vessel. The
amount of tension
applied to the
vessel for
occlusion or
partial occlusion
is adjusted by
means of the
ratchet closure | | Material | Stainless Steel | Stainless Steel,
Titanium | Stainless Steel | | Sterility | Non-sterile | Non-sterile | Non-sterile | | Reusable | Yes | Yes | Yes | Conclusion: The information provided in this 510(k) submission provides reasonable assurance that the subject device Vascular Clamps is safe and effective and that it is substantially equivalent to the predicate device with respect to intended use and technological characteristics. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 14, 2013 HEBUmedical GmbH Attention: Angelika Scherp Regulatory Affairs Consultant Badstrasse 8 78532 Tuttlingen, Germany Re: K123077 Trade Name: Vascular Clamps Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: April 24, 2013 Received: May 7, 2013 Dear Ms. Scherp: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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 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 {3}------------------------------------------------ Page 2 - Ms. Angelika Scherp 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 vours. # Bram D. Z@Ckerman -S Bram D. Zuckerman. M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## INDICATIONS FOR USE 510(k) Number (if known): K123077 Device Name: VASCULAR CLAMPS Indications for Use: Vascular Clamps are indicated for use for temporary or partial occlusion of blood vessels during open surgical procedures. Prescription Use __ X__ . (Part 21 CFR 80) Subpart D) AND/OR Over-The-Counter Use _ (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Image /page/4/Picture/9 description: The image shows the text "Bram D. Zuckerman - S 2013.05.14 14:45:56 -04'00'". The text appears to be a timestamp or a record of some kind. The text is black and is set against a white background. Page 1 of _________ - --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXC/K123077](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXC/K123077) **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