BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT
Device Facts
| Record ID | K962177 |
|---|---|
| Device Name | BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT |
| Applicant | C.R. Bard, Inc. |
| Product Code | DSP · Cardiovascular |
| Decision Date | Sep 4, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.3535 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
Refractory left ventricular failure, Cardiogenic or septic shock, Unstable refractory angina, Impending infarction, Ischemia related ventricular arrhythmias, Weaning from cardiopulmonary bypass, Support and stabilization during coronary angioplasty, Intraoperative pulsatile flow generation, Associated mechanical complications of acute myocardial infarction, Support and stabilization of high-risk patients undergoing general surgical procedures.
Device Story
Intra-aortic balloon (IAB) catheter; percutaneous insertion; double-lumen design; pre-furled balloon; integrated sliding hemostasis device for puncture site bleeding control. Used in clinical settings (OR/ICU) by physicians for hemodynamic support. Device functions as mechanical circulatory assist; inflates/deflates to augment cardiac output; reduces myocardial oxygen demand. Kit includes insertion accessories (introducer, guidewires, needle, dilator) and console adaptors. Output is mechanical pulsatile flow; assists clinical decision-making by stabilizing hemodynamics in acute cardiac failure or high-risk surgical patients.
Clinical Evidence
Bench testing only. Testing verified the catheter's ability to withstand insertion forces associated with sheathless insertion. No clinical data provided.
Technological Characteristics
Double-lumen catheter; materials include polyurethane, silicone, stainless steel, polycarbonate, polyolefin, and thermoplastic elastomer. Features pre-furled balloon and integrated sliding hemostasis device. Dimensions: 30cc and 40cc volumes. Mechanical device; no energy source or software.
Indications for Use
Indicated for patients experiencing refractory left ventricular failure, cardiogenic or septic shock, unstable refractory angina, impending infarction, ischemia-related ventricular arrhythmias, need for weaning from cardiopulmonary bypass, support during coronary angioplasty, intraoperative pulsatile flow, mechanical complications of acute myocardial infarction, or high-risk general surgical procedures.
Regulatory Classification
Identification
An intra-aortic balloon and control system is a prescription device that consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning during certain life-threatening emergencies, and a control system for regulating the inflation and deflation of the balloon. The control system, which monitors and is synchronized with the electrocardiogram, provides a means for setting the inflation and deflation of the balloon with the cardiac cycle.
Special Controls
*Classification.* (1) Class II (special controls) when the device is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure. The special controls for this device are:(i) Appropriate analysis and non-clinical testing must be conducted to validate electromagnetic compatibility and electrical safety of the device; (ii) Software verification, validation, and hazard analysis must be performed; (iii) The device must be demonstrated to be biocompatible; (iv) Sterility and shelf-life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; (v) Non-clinical performance evaluation of the device must demonstrate mechanical integrity, durability, and reliability to support its intended purpose; and (vi) Labeling must include a detailed summary of the device- and procedure-related complications pertinent to use of the device. (2) Class III (premarket approval) when the device is indicated for septic shock and pulsatile flow generation. (c) *Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required.* A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 31, 2014, for any intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation that was in commercial distribution before May 28, 1976, or that has, on or before March 31, 2014, been found to be substantially equivalent to any intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation that was in commercial distribution before May 28, 1976. Any other intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
Predicate Devices
- Sheathless 40cc Pre-Wrapped Double-Lumen 9.0 F. Intra-Aortic Balloon Catheter (Model IAB-04240S)
Related Devices
- K973962 — BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS · C.R. Bard, Inc. · Feb 19, 1998
- K981660 — Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters · C.R. Bard, Inc. · Oct 16, 1998
- K980850 — BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOONS · C.R. Bard, Inc. · Jun 3, 1998
- K980780 — DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES · Datascope Corp. · May 29, 1998
- K980385 — DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR OPTIONAL SHEATHLESS INSERTION WITH ACCESSORIES · Datascope Corp. · May 1, 1998
