← Product Code [MAV](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV) · K961471 # INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE) (K961471) _Advanced Cardiovascular Systems, Inc. · MAV · May 8, 1996 · Cardiovascular · SESK_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV/K961471 ## Device Facts - **Applicant:** Advanced Cardiovascular Systems, Inc. - **Product Code:** [MAV](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV.md) - **Decision Date:** May 8, 1996 - **Decision:** SESK - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1650 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic ## Indications for Use INDEFLATOR 20/30™ Inflation Device- The INDEFLATOR 20/30™ Inflation Device is recommended for use during cardiovascular procedures in conjunction with interventional devices such as balloon catheters to create and monitor pressure in the balloon catheter. 20/30 PRIORITY PACK™ Accessory Kit- The Accessory Kit is recommended for use during cardiovascular procedures in conjunction with interventional and/or diagnostic devices (e.g., balloon dilatation catheters, artherectomy devices, stent delivery systems, intravascular ultrasound devices.) ## Device Story Manually operated inflation device; creates and monitors pressure in balloon catheters during cardiovascular procedures. Includes pressure gauge for monitoring. 20/30 PRIORITY PACK™ includes inflation device plus accessories: torque device, guide wire introducer, rotating hemostatic valve. Used by clinicians in cardiovascular settings to facilitate interventional/diagnostic device deployment. Output is controlled pressure for balloon inflation; enables physician to perform angioplasty or stent delivery. Benefits patient by allowing precise control of interventional device expansion. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Manually operated mechanical inflation device. Includes pressure gauge, torque device, guide wire introducer, and rotating hemostatic valve. Non-powered. No software or electronic components. ## Special Controls *Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, 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 - ACS INDEFLATOR 20/20™ ([K872981](/device/K872981.md)) - Baxter Inflation Pro™ II ([K895836](/device/K895836.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} GUIDANT K961471 # SUMMARY OF SAFETY AND EFFECTIVENESS ## 510(k) Summary ### INDEFLATOR 20/30™ Inflation Device and 20/30 PRIORITY PACK™ **Device Name:** INDEFLATOR 20/30™ Inflation Device 20/30 PRIORITY PACK™ Accessory Kit **Devices to which Equivalence is Claimed:** ACS INDEFLATOR 20/20™ (K872981, October 20, 1987 and Baxter Inflation Pro™ II inflation device (K895836, December 20, 1989). **Indication for Use:** **INDEFLATOR 20/30™ Inflation Device-** The INDEFLATOR 20/30™ Inflation Device is recommended for use during cardiovascular procedures in conjunction with interventional devices such as balloon catheters to create and monitor pressure in the balloon catheter. **20/30 PRIORITY PACK™ Accessory Kit-** The Accessory Kit is recommended for use during cardiovascular procedures in conjunction with interventional and/or diagnostic devices (e.g., balloon dilatation catheters, artherectomy devices, stent delivery systems, intravascular ultrasound devices.) **Device Description:** The INDEFLATOR 20/30™ Inflation Device is a manually operated device used to pressurize and depressurize balloon catheters. Pressure can be monitored via a pressure gauge. The 20/30 PRIORITY PACK™ is comprised of the INDEFLATOR 20/30™ inflation device packaged with accessories used during vascular procedures in conjunction with interventional or diagnostic devices. These accessories include a torque device, a guide wire introducer and a rotating hemostatic valve. GUIDANT CORPORATION ADVANCED CARDIOVASCULAR SYSTEMS 26531 YNEZ ROAD P.O. BOX 9810 TEMECULA, CA 92591-4628 TEL 909-914-2400 P0 128 43 {1} GUIDANT # SUMMARY OF SAFETY AND EFFECTIVENESS (continued) Summary of Substantial Equivalence: The indications, methods and conditions of use, packaging process and location, sterilization process and location are similar to those of the currently marketed ACS INDEFLATOR 20/20™ Inflation Device. The 20/30 PRIORITY PACK™ includes accessories that have been previously cleared and the INDEFLATOR 20/30™ Inflation device, which is similar to the ACS INDEFLATOR 20/20™ Inflation device. The indications for use are similar to the Baxter Edwards Inflation Pro™ II. The INDEFLATOR 20/30™ Inflation Device is similar in design and indicated use to the predicate devices. Conclusion: The INDEFLATOR 20/30™ Inflation Device is substantially equivalent to the currently marketed ACS INDEFLATOR 20/20™ and the Baxter Edwards Inflation Pro™ II. GUIDANT CORPORATION ADVANCED CARDIOVASCULAR SYSTEMS 26531 YNEZ ROAD P.O. BOX 9810 TEMECULA, CA 92591-4628 TEL 909-914-2400 19112943 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV/K961471](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV/K961471) **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. 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