DWS — Instruments, Surgical, Cardiovascular Class I
FDA Device Classification
Classification Details
- Product Code
- DWS
- Device Class
- Class I
- Regulation Number
- 870.4500
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K022238 | medtronic vascular | MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 | October 9, 2002 |
| K964445 | dlp | OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) | January 30, 1997 |
| K962771 | pilling weck | BURKE CONGENITAL THORACOSCOPY INSTRUMENTS | November 19, 1996 |
| K955689 | contour fabricators of florida | RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY | May 15, 1996 |
| K960139 | ge medical systems | G.E. STERILE ANGIOGRAPHIC TRAY | April 19, 1996 |
| K960144 | ge medical systems | G.E. STERILE CT BIOPSY TRAY | April 15, 1996 |
| K960143 | ge medical systems | G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY | April 9, 1996 |
| K934727 | cardiac pacemakers | REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER | January 10, 1994 |
| K900379 | st. jude medical | HYCULT DIAMOND CORONARY BYPASS KNIFE | March 19, 1990 |
| K896307 | bio-vascular | INSULATION PAD | January 19, 1990 |
| K894738 | cardiac pacemakers | MODEL 6888 LEAD TUNNELER | September 13, 1989 |
| K892804 | acacia laboratories | NEWCHILL(TM) CARDIAC INSULATOR | July 14, 1989 |
| K893436 | pioneering technologies | MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT | July 14, 1989 |
| K891000 | instromedix | MODIFIED EXTERNAL PAD | May 19, 1989 |
| K890432 | deknatel | DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM) | April 13, 1989 |
| K890707 | dlp | PHRENIC NERVE PAD & NERVE PAD W/1/4 PERCARDIAL | April 10, 1989 |
| K882981 | pioneering technologies | PTI INTRA-ART CORONARY ARTERY RETRACTION CLIP | September 27, 1988 |
| K883135 | pioneering technologies | PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE) | September 26, 1988 |
| K882367 | metatech | METATECH MICROCLIP APPLICATOR | August 25, 1988 |
| K881796 | universal medical instrument | UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE | July 26, 1988 |