Product code DWS
- Device name
- Instruments, Surgical, Cardiovascular
- Medical specialty
- Cardiovascular
- Device class
- 1
- Regulation number
- 870.4500
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K022238 | MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 | Medtronic Vascular | 2002-10-09 |
| K964445 | OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) | Dlp, Inc. | 1997-01-30 |
| K962771 | BURKE CONGENITAL THORACOSCOPY INSTRUMENTS | Pilling Weck, Inc. | 1996-11-19 |
| K955689 | RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY | Contour Fabricators of Florida, Inc. | 1996-05-15 |
| K960139 | G.E. STERILE ANGIOGRAPHIC TRAY | GE Medical Systems | 1996-04-19 |
| K960144 | G.E. STERILE CT BIOPSY TRAY | GE Medical Systems | 1996-04-15 |
| K960143 | G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY | GE Medical Systems | 1996-04-09 |
| K934727 | REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER | Cardiac Pacemakers, Inc. | 1994-01-10 |
| K900379 | HYCULT DIAMOND CORONARY BYPASS KNIFE | St. Jude Medical, Inc. | 1990-03-19 |
| K896307 | INSULATION PAD | Bio-Vascular, Inc. | 1990-01-19 |
| K894738 | MODEL 6888 LEAD TUNNELER | Cardiac Pacemakers, Inc. | 1989-09-13 |
| K892804 | NEWCHILL(TM) CARDIAC INSULATOR | Acacia Laboratories, Inc. | 1989-07-14 |
| K893436 | MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT | Pioneering Technologies, Inc. | 1989-07-14 |
| K891000 | MODIFIED EXTERNAL PAD | Instromedix, Inc. | 1989-05-19 |
| K890432 | DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM) | Deknatel, Inc. | 1989-04-13 |
| K890707 | PHRENIC NERVE PAD & NERVE PAD W/1/4 PERCARDIAL | Dlp, Inc. | 1989-04-10 |
| K882981 | PTI INTRA-ART CORONARY ARTERY RETRACTION CLIP | Pioneering Technologies, Inc. | 1988-09-27 |
| K883135 | PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE) | Pioneering Technologies, Inc. | 1988-09-26 |
| K882367 | METATECH MICROCLIP APPLICATOR | Metatech Corp. | 1988-08-25 |
| K881796 | UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE | Universal Medical Instrument Corp. | 1988-07-26 |
| K882479 | 26MM DIAMETER HANCOCK* TROCAR BLADE AND TIP | Medtronic Blood Systems, Inc. | 1988-07-18 |
| K881717 | PTI HEART-LIFT(TM) CARDIAC SUPPORT SLING (STERILE) | Buckman Co., Inc. | 1988-07-05 |
| K881392 | CARDICAD(TM) | Medical/Surgical Specialties, Ltd. | 1988-05-31 |
| K875016 | BIOSURGE MODEL ILVC-1 | Biosurge, Inc. | 1988-02-29 |
| K874960 | CARDIOVASCULAR SURGICAL INSTRUMENTS | Solway, Inc. | 1988-02-05 |
| K864461 | MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE TRAY | Medsurg Industries, Inc. | 1986-11-24 |
| K861745 | VICKERS ERGOMATIC MICROSURG INSTRU CARDIAC SET | Keeler Instruments, Inc. | 1986-05-13 |
| K851825 | SCANLAN TUNNELER, SHEATH & TIP | Scanlan Intl., Inc. | 1985-07-12 |
| K851832 | NAMAN POTTS COURNAND NEEDLE | Manan Manufacturing Co., Inc. | 1985-07-11 |
| K851833 | MANAN SELDINGER NEEDLE | Manan Manufacturing Co., Inc. | 1985-07-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00190776423971 | Millennium | Avalign Technologies, Inc. | 2026-08-27 |
| 00190776424114 | Millennium | Avalign Technologies, Inc. | 2026-08-27 |
| 00190776424138 | Millennium | Avalign Technologies, Inc. | 2026-08-27 |
| 00884450450970 | Merit Medical® | Merit Medical Systems, Inc. | 2026-08-27 |
| 00190776423933 | Millennium | Avalign Technologies, Inc. | 2026-08-27 |
| 00190776419707 | Millennium | Avalign Technologies, Inc. | 2026-08-25 |
| 00190776420284 | Millennium | Avalign Technologies, Inc. | 2026-08-25 |
| 00190776420390 | Millennium | Avalign Technologies, Inc. | 2026-08-25 |
| 04058749004496 | NA | Fehling Instruments GmbH & Co. KG | 2026-08-25 |
| 00190776417130 | Millennium | Avalign Technologies, Inc. | 2026-08-19 |
| 00198506094064 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-08-18 |
| 00190776417000 | Millennium | Avalign Technologies, Inc. | 2026-08-18 |
| 00190776416973 | Millennium | Avalign Technologies, Inc. | 2026-08-18 |
| 00190776411107 | Millennium | Avalign Technologies, Inc. | 2026-08-07 |
| 00190776411473 | Millennium | Avalign Technologies, Inc. | 2026-08-07 |
| 00190776411497 | Millennium | Avalign Technologies, Inc. | 2026-08-07 |
| 00190776411510 | Millennium | Avalign Technologies, Inc. | 2026-08-07 |
| 00190776408732 | Millennium | Avalign Technologies, Inc. | 2026-08-03 |
| 03661219141778 | DELACROIX-CHEVALIER | LANDANGER | 2026-08-02 |
| 03661219141785 | DELACROIX-CHEVALIER | LANDANGER | 2026-08-02 |
| 14026704916679 | PILLING | TELEFLEX INCORPORATED | 2026-08-01 |
| 00190776407438 | Millennium | Avalign Technologies, Inc. | 2026-07-31 |
| 00190776407513 | Millennium | Avalign Technologies, Inc. | 2026-07-31 |
| 07640174510412 | Biover Titanium Microsurgical Instruments | Biover AG | 2024-10-30 |
| 07640174510405 | Biover Titanium Microsurgical Instruments | Biover AG | 2023-02-28 |
| 07640174510399 | Biover Titanium Microsurgical Instruments | Biover AG | 2023-02-28 |
| 07640174510382 | Biover Titanium Microsurgical Instruments | Biover AG | 2023-02-28 |
| 07640174510375 | Biover Titanium Microsurgical Instruments | Biover AG | 2023-02-28 |
| 07640174510368 | Biover Titanium Microsurgical Instruments | Biover AG | 2023-02-28 |
| 07640174510351 | Biover Titanium Microsurgical Instruments | Biover AG | 2023-02-28 |