Tape, Vascular, 1/4 Dacron
FDA 510(k) K760087 · Meadox Medicals, Div. Boston Scientific Corp.
510(k) numberK760087
Submission
- Device name
- Tape, Vascular, 1/4 Dacron
- Applicant
- Meadox Medicals, Div. Boston Scientific Corp.
Mchenry, IL, US - Received
- June 21, 1976
- Decision date
- July 20, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DWS – Instruments, Surgical, Cardiovascular
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.4500
- Specialty
- Cardiovascular
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|---|---|---|---|
| K022238 | Myocardial Lead Implant Tool, Model 10626DWS · Traditional | Medtronic Vascular | 10/09/2002SE |
| K964445 | Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006)DWS · Traditional | Dlp, Inc. | 01/30/1997SE |
| K962771 | Burke Congenital Thoracoscopy InstrumentsDWS · Traditional | Pilling Weck, Inc. | 11/19/1996SE |
| K955689 | RNS Sterile, Disposable Digital Angiographic TrayDWS · Traditional | Contour Fabricators of Florida, Inc. | 05/15/1996SE |
| K960139 | G.E. Sterile Angiographic TrayDWS · Traditional | GE Medical Systems | 04/19/1996SESK |
| K960144 | G.E. Sterile CT Biopsy TrayDWS · Traditional | GE Medical Systems | 04/15/1996SESK |
| K960143 | G.E. Sterile Digital Angiographic TrayDWS · Traditional | GE Medical Systems | 04/09/1996SESK |
| K934727 | Replacement Parts for Cpi 6888 Lead TunnelerDWS · Traditional | Cardiac Pacemakers, Inc. | 01/10/1994SE |
| K900379 | Hycult Diamond Coronary Bypass KnifeDWS · Traditional | St. Jude Medical, Inc. | 03/19/1990SE |
| K896307 | Insulation PadDWS · Traditional | Bio-Vascular, Inc. | 01/19/1990SE |
More from Bio-Vascular, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K953647 | MS Classique Balloon Catheter W/Hydropass CoatingLIT · Traditional | 05/16/1997SE |
| K960766 | Meadox Medicals, Inc. Expanded PTFE Vascular GraftDYF · Traditional | 03/19/1997ST |
| K962433 | Meadox Exxcel Eptfe Vascular GraftDSY · Traditional | 03/17/1997ST |
| K961847 | Hemashield Vantage (Vascular GraftDSY · Traditional | 01/22/1997ST |
| K962342 | Hemashield Finesse Ultra-Thin, Knitted Cardiovascular PatchDXZ · Traditional | 09/10/1996SE |
| K955460 | Meadox Medicals, Inc., Expanded & Externally Supported Expanded PTFE Vascular GraftDSY · Traditional | 05/30/1996ST |
| K952884 | Noprofile Olbert Catheter System Balloon Dilatation CatheterLIT · Traditional | 02/21/1996SE |
| K955349 | Hemashield Knitted Double Velour Cardiovascular FabricDXZ · Traditional | 02/14/1996SE |
| K953298 | MS Classique Balloon Diatation CatheterLIT · Traditional | 02/08/1996SE |
| K954848 | Hemashield Microvel Velour Knitted Vascular GraftMAL · Traditional | 02/01/1996ST |
Questions and answers
When was Tape, Vascular, 1/4 Dacron cleared by the FDA?
Tape, Vascular, 1/4 Dacron (K760087) received a 510(k) decision of Substantially Equivalent on July 20, 1976, 29 days after the submission was received.
What is the product code of K760087?
The FDA product code is DWS – Instruments, Surgical, Cardiovascular, a Class I (low risk) device regulated under 21 CFR 870.4500.