Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4500](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4500) → DWS — Instruments, Surgical, Cardiovascular # DWS · Instruments, Surgical, Cardiovascular _Cardiovascular · 21 CFR 870.4500 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWS ## Overview - **Product Code:** DWS - **Device Name:** Instruments, Surgical, Cardiovascular - **Regulation:** [21 CFR 870.4500](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4500) - **Device Class:** 1 - **Review Panel:** [Cardiovascular](/submissions/CV) ## Identification Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors. ## Classification Rationale Class I (general 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. ## Recent Cleared Devices (20 of 71) Showing 20 most recent of 71 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K022238](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWS/K022238.md) | MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 | Medtronic Vascular | Oct 9, 2002 | SESE | | [K964445](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWS/K964445.md) | OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) | Dlp, Inc. | Jan 30, 1997 | SESE | | [K962771](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWS/K962771.md) | BURKE CONGENITAL THORACOSCOPY INSTRUMENTS | Pilling Weck, Inc. | Nov 19, 1996 | SESE | | [K955689](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWS/K955689.md) | RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY | Contour Fabricators of Florida, Inc. | May 15, 1996 | SESE | | [K960139](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWS/K960139.md) | G.E. STERILE ANGIOGRAPHIC TRAY | GE Medical Systems | Apr 19, 1996 | SESK | | [K960144](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWS/K960144.md) | G.E. STERILE CT BIOPSY TRAY | GE Medical Systems | Apr 15, 1996 | SESK | | [K960143](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWS/K960143.md) | G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY | GE Medical Systems | Apr 9, 1996 | SESK | | [K934727](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWS/K934727.md) | REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER | Cardiac Pacemakers, Inc. | Jan 10, 1994 | SESE | | [K900379](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWS/K900379.md) | HYCULT DIAMOND CORONARY BYPASS KNIFE | St. Jude Medical, Inc. | Mar 19, 1990 | SESE | | [K896307](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWS/K896307.md) | INSULATION PAD | Bio-Vascular, Inc. | Jan 19, 1990 | SESE | | [K894738](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWS/K894738.md) | MODEL 6888 LEAD TUNNELER | Cardiac Pacemakers, Inc. | Sep 13, 1989 | SESE | | [K893436](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWS/K893436.md) | MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT | Pioneering Technologies, Inc. | Jul 14, 1989 | SESE | | [K892804](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWS/K892804.md) | NEWCHILL(TM) CARDIAC INSULATOR | Acacia Laboratories, Inc. | Jul 14, 1989 | SESE | | [K891000](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWS/K891000.md) | MODIFIED EXTERNAL PAD | Instromedix, Inc. | May 19, 1989 | SESE | | [K890432](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWS/K890432.md) | DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM) | Deknatel, Inc. | Apr 13, 1989 | SESE | | [K890707](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWS/K890707.md) | PHRENIC NERVE PAD & NERVE PAD W/1/4 PERCARDIAL | Dlp, Inc. | Apr 10, 1989 | SESE | | [K882981](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWS/K882981.md) | PTI INTRA-ART CORONARY ARTERY RETRACTION CLIP | Pioneering Technologies, Inc. | Sep 27, 1988 | SESE | | [K883135](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWS/K883135.md) | PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE) | Pioneering Technologies, Inc. | Sep 26, 1988 | SESE | | [K882367](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWS/K882367.md) | METATECH MICROCLIP APPLICATOR | Metatech Corp. | Aug 25, 1988 | SESE | | [K881796](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWS/K881796.md) | UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE | Universal Medical Instrument Corp. | Jul 26, 1988 | SESE | ## Top Applicants - Edward Weck, Inc. — 3 clearances - GE Medical Systems — 3 clearances - Manan Manufacturing Co., Inc. — 3 clearances - Pilling Co. — 3 clearances - Pioneering Technologies, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWS](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWS) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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