DWS · Instruments, Surgical, Cardiovascular
Cardiovascular · 21 CFR 870.4500 · Class 1
Overview
| Product Code | DWS |
|---|---|
| Device Name | Instruments, Surgical, Cardiovascular |
| Regulation | 21 CFR 870.4500 |
| Device Class | Class 1 |
| Review Panel | Cardiovascular |
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 | MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 | Medtronic Vascular | Oct 9, 2002 | SESE |
| K964445 | OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) | Dlp, Inc. | Jan 30, 1997 | SESE |
| K962771 | BURKE CONGENITAL THORACOSCOPY INSTRUMENTS | Pilling Weck, Inc. | Nov 19, 1996 | SESE |
| K955689 | RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY | Contour Fabricators of Florida, Inc. | May 15, 1996 | SESE |
| K960139 | G.E. STERILE ANGIOGRAPHIC TRAY | GE Medical Systems | Apr 19, 1996 | SESK |
| K960144 | G.E. STERILE CT BIOPSY TRAY | GE Medical Systems | Apr 15, 1996 | SESK |
| K960143 | G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY | GE Medical Systems | Apr 9, 1996 | SESK |
| K934727 | REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER | Cardiac Pacemakers, Inc. | Jan 10, 1994 | SESE |
| K900379 | HYCULT DIAMOND CORONARY BYPASS KNIFE | St. Jude Medical, Inc. | Mar 19, 1990 | SESE |
| K896307 | INSULATION PAD | Bio-Vascular, Inc. | Jan 19, 1990 | SESE |
| K894738 | MODEL 6888 LEAD TUNNELER | Cardiac Pacemakers, Inc. | Sep 13, 1989 | SESE |
| K893436 | MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT | Pioneering Technologies, Inc. | Jul 14, 1989 | SESE |
| K892804 | NEWCHILL(TM) CARDIAC INSULATOR | Acacia Laboratories, Inc. | Jul 14, 1989 | SESE |
| K891000 | MODIFIED EXTERNAL PAD | Instromedix, Inc. | May 19, 1989 | SESE |
| K890432 | DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM) | Deknatel, Inc. | Apr 13, 1989 | SESE |
| K890707 | PHRENIC NERVE PAD & NERVE PAD W/1/4 PERCARDIAL | Dlp, Inc. | Apr 10, 1989 | SESE |
| K882981 | PTI INTRA-ART CORONARY ARTERY RETRACTION CLIP | Pioneering Technologies, Inc. | Sep 27, 1988 | SESE |
| K883135 | PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE) | Pioneering Technologies, Inc. | Sep 26, 1988 | SESE |
| K882367 | METATECH MICROCLIP APPLICATOR | Metatech Corp. | Aug 25, 1988 | SESE |
| K881796 | 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
