← Product Code [CAC](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC) · K964070 # DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG (K964070) _Deknatel, Inc. · CAC · Dec 31, 1996 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC/K964070 ## Device Facts - **Applicant:** Deknatel, Inc. - **Product Code:** [CAC](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC.md) - **Decision Date:** Dec 31, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.5830 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** Therapeutic ## Indications for Use The Pleur-evac® Autotransfusion Blood Recovery Bag is a blood evacuation and collection device for shed mediastinal or pleural drainage, and is intended to be used in conjunction with DSP Pleur-evac® Continuous Reinfusion Autotransfusion Systems. ## Device Story Flexible PVC bag for collection of shed mediastinal/pleural blood; used with Pleur-evac® Continuous Reinfusion Autotransfusion Systems. Device features two spring-loaded plates; unlatching plates creates vacuum to draw blood from thoracic drainage unit into bag for reinfusion. Used in clinical settings by healthcare providers. Benefits include efficient recovery and reinfusion of patient's own blood. ## Clinical Evidence No clinical data provided; substantial equivalence established via identical design and materials to predicate device. ## Technological Characteristics Flexible PVC bag; spring-loaded plate mechanism for vacuum generation; manual operation; non-powered. ## Regulatory Identification An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma. ## Predicate Devices - Atrium Self-filling ATS Blood Bag, model 2450 ([K883663](/device/K883663.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} K964070 DEC 31 1996 # 510(k) SUMMARY ## DEKNATEL DSP ### Pleur-evac® Autotransfusion Blood Recovery Bag 1. **DATE PREPARED** October 8, 1996 2. **SPONSOR INFORMATION** **Address:** Deknatel DSP Worldwide, Inc. 600 Airport Road Fall River, Massachusetts 02720 **Telephone:** 508-677-6600 **Contact:** Dean E. Ciporkin Director of Regulatory Affairs 3. **DEVICE NAME** **Proprietary Name:** Pleur-evac® Autotransfusion Blood Recovery Bag **Common/Usual Name:** Autotransfusion blood bag **Classification Name:** Autotransfusion apparatus 4. **DEVICE DESCRIPTION AND INTENDED USE** The Pleur-evac® Autotransfusion Blood Recovery Bag is a blood evacuation and collection device for shed mediastinal or pleural drainage, and is intended to be used in conjunction with DSP Pleur-evac® Continuous Reinfusion Autotransfusion Systems. The device is a flexible PVC bag designed to evacuate and collect filtered blood from a thoracic drainage unit for reinfusion to the patient. The bag contains two spring-loaded plates which are latched together prior to device use. During use, the plates are unlatched and the spring acts against the plates to create a vacuum in the bag thereby drawing the blood into the bag from the Pleur-evac® unit. Deknatel DSP 510(k) Pleur-evac® Autotransfusion Blood Recovery Bag 10/8/96 Page C-1 {1} # 5. COMPARISON TO PREDICATE DEVICES The Pleur-evac® Autotransfusion Blood Recovery Bag is identical in design, materials, manufacturing process, function, and intended use to the predicate device (Atrium Self-filling ATS Blood Bag, model 2450 --K883663). The only difference in the two devices is in the actual product labeling, which identifies the specific trade names and information on the specific distributors. Since the Pleur-evac® Autotransfusion Blood Recovery Bag is identical to the predicate device, no additional performance or biocompatibility testing was provided in this submission in order to establish substantial equivalence of the device to the predicate product. Deknatel DSP 510(k) Pleur-evac® Autotransfusion Blood Recovery Bag 10/8/96 Page C-2 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC/K964070](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAC/K964070) **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