Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4475](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4475) → DWP — Dilator, Vessel, Surgical # DWP · Dilator, Vessel, Surgical _Cardiovascular · 21 CFR 870.4475 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP ## Overview - **Product Code:** DWP - **Device Name:** Dilator, Vessel, Surgical - **Regulation:** [21 CFR 870.4475](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4475) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## Identification A surgical vessel dilator is a device used to enlarge or calibrate a vessel. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 20) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K220981](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP/K220981.md) | SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe | Fehling Surgical Instruments, Inc. | Apr 20, 2023 | SESE | | [K183438](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP/K183438.md) | Geomed Vascular Dilators | Geomed Medizin-Technik GmbH & Co. | Sep 3, 2019 | SESE | | [K163524](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP/K163524.md) | Vessel Dilator | Fetzer Medical GmbH & Co. KG | Jun 29, 2017 | SESE | | [K130896](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP/K130896.md) | VASCULAR PROBE, VASCULAR PROBE ES | Synovis Life Technologies, Inc. | Apr 24, 2013 | SESE | | [K100518](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP/K100518.md) | INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 | Instrumed International, Inc. | Aug 31, 2010 | SESE | | [K030788](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP/K030788.md) | KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS | Geister Medizin Technik GmbH | Jul 12, 2003 | SESE | | [K960312](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP/K960312.md) | RDI CARDIAC INSULATION PAD | R D Intl. | Apr 19, 1996 | SESE | | [K912548](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP/K912548.md) | LEMAITRE-BOOKWALTER VESSEL DEVICES | Vascutech, Inc. | Sep 18, 1991 | SESE | | [K911475](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP/K911475.md) | LAPAROSCOPIC VESSEL ARTICULATOR | United States Endoscopy Group, Inc. | Jul 2, 1991 | SESE | | [K910682](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP/K910682.md) | ROBICSEK PROBE/RETRACTOR | Bio-Vascular, Inc. | May 8, 1991 | SESE | | [K905159](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP/K905159.md) | FLO-RESTER(R) VESSEL SIZER | Bio-Vascular, Inc. | Feb 7, 1991 | SESE | | [K902143](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP/K902143.md) | FOGARTY VESSEL CALIBRATOR | Baxter Healthcare Corp | Oct 16, 1990 | SESE | | [K891786](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP/K891786.md) | PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE) | Pioneering Technologies, Inc. | Oct 12, 1989 | SESE | | [K833676](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP/K833676.md) | SURGICAL VESSEL DILATORS-CATHERIZA- | Cimed Intl., Inc. | Mar 19, 1984 | SESE | | [K832595](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP/K832595.md) | VESSEL DILATOR | Abbott Laboratories | Aug 31, 1983 | SESE | | [K822687](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP/K822687.md) | REUSABLE FOGARTY FLEXIBLE CALIBRATOR | American Edwards Laboratories | Oct 4, 1982 | SESE | | [K812935](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP/K812935.md) | FOGARTY FLEXIBLE PROBE | American Edwards Laboratories | Nov 16, 1981 | SESE | | [K810894](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP/K810894.md) | FOGARTY FLEXIBLE CALIBRATOR | American Edwards Laboratories | May 15, 1981 | SESE | | [K792134](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP/K792134.md) | BONCHEK-SHILEY VEIN DISTENTION SYSTEM | Shiley, Inc. | Dec 4, 1979 | SESE | | [K790938](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP/K790938.md) | SAPHENOUS VEIN IRRIGATION, PRESSURIZATIO | Shiley, Inc. | Jun 13, 1979 | SESE | ## Top Applicants - American Edwards Laboratories — 3 clearances - Shiley, Inc. — 2 clearances - Bio-Vascular, Inc. — 2 clearances - Vascutech, Inc. — 1 clearance - United States Endoscopy Group, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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