KRI · Accessory Equipment, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4200 · Class 1
Overview
| Product Code | KRI |
|---|---|
| Device Name | Accessory Equipment, Cardiopulmonary Bypass |
| Regulation | 21 CFR 870.4200 |
| Device Class | Class 1 |
| Review Panel | Cardiovascular |
Identification
Cardiopulmonary bypass accessory equipment is a device that has no contact with blood and that is used in the cardiopulmonary bypass circuit to support, adjoin, or connect components, or to aid in the setup of the extracorporeal line, e.g., an oxygenator mounting bracket or system-priming equipment.
Classification Rationale
(1) Class I. The device is classified as class I if it does not involve an electrical connection to the patient. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 870.9.(2) Class II (special controls). The device is classified as class II if it involves an electrical connection to the patient. The special controls are as follows: (i) The performance standard under part 898 of this chapter, and (ii) The guidance document entitled “Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 870.9.
Special Controls
*Classification.* (1) Class I. The device is classified as class I if it does not involve an electrical connection to the patient. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 870.9.(2) Class II (special controls). The device is classified as class II if it involves an electrical connection to the patient. The special controls are as follows: (i) The performance standard under part 898 of this chapter, and (ii) The guidance document entitled “Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 870.9.
Recent Cleared Devices (20 of 42)
Showing 20 most recent of 42 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K020365 | 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE | 3t Medical Systems, LLC | May 3, 2002 | SESE |
| K992635 | INTERFACE MODULE IDDD | Stoeckert Instrumente | Dec 20, 1999 | SESE |
| K990512 | STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS | Stoeckert Instrumente | Nov 23, 1999 | SESE |
| K934782 | AMMEX TUBING ORGANIZER | Ammex Cardiopulmonary Corp. | Nov 18, 1993 | SESE |
| K926233 | CARDIO2 CYCLE | Ergometrix, Inc. | Jun 4, 1993 | SESE |
| K922404 | TUBE GRIP | Georgia Medical Products, Inc. | Nov 23, 1992 | SESE |
| K892856 | NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS | Acacia Laboratories, Inc. | Nov 8, 1989 | SESE |
| K884893 | CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 | American Omni Medical, Inc. | Jan 30, 1989 | SESE |
| K884640 | CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 | American Omni Medical, Inc. | Jan 24, 1989 | SESE |
| K874605 | HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR | Mallinckrodt Critical Care | Feb 2, 1988 | SESE |
| K874925 | CPE 2000 CARDIO PULMONARY ERGOMETER | Medical Graphics Corp. | Jan 19, 1988 | SESE |
| K864890 | STOCKERT-SHILEY CAPS VENOUS OCCLUSION CLAMP | Shiley, Inc. | Feb 19, 1987 | SESE |
| K862510 | STOCKERT-SHILEY CAPS 4 CHANNEL TEMP. MONITOR 1 | Shiley, Inc. | Jul 17, 1986 | SESE |
| K862549 | ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE | American Bentley | Jul 15, 1986 | SESE |
| K860298 | STABLELINE | Cardio Metrics, Inc. | Apr 2, 1986 | SESE |
| K860672 | ADJUSTABLE OXYGENATOR HOLDER MODEL NO. BCM-HL | American Bentley | Mar 3, 1986 | SESE |
| K854113 | CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH | American Bentley | Jan 8, 1986 | SESE |
| K852455 | GAMBRO DIGITAL TELETHERMOMETER TTH 10-200 | Gambro, Inc. | Sep 16, 1985 | SESE |
| K851077 | CARDIAC COOLING JACKET | Pat O. Daily | Jul 11, 1985 | SESE |
| K851289 | COBE GAS FILTER | Cobe Laboratories, Inc. | Jun 19, 1985 | SESE |
Top Applicants
- American Bentley — 7 clearances
- Shiley, Inc. — 4 clearances
- Texas Medical Products, Inc. — 3 clearances
- Stoeckert Instrumente — 2 clearances
- Bentley Laboratories, Inc. — 2 clearances
