Scanlan Tunneler, Sheath & Tip
FDA 510(k) K851825 · Scanlan Intl., Inc.
510(k) numberK851825
Submission
- Device name
- Scanlan Tunneler, Sheath & Tip
- Applicant
- Scanlan Intl., Inc.
Saint Paul, MN, US - Received
- April 26, 1985
- Decision date
- July 12, 1985
- 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 |
|---|---|---|
| K960372 | Scanlan Heifetz Aneurysm Elgiloy Clip SystemHCH · Traditional | 04/26/1996SE |
| K945474 | Scanlan(R) Thoracoscopic Scissors, Clamp, Forceps, Needle HolderGCJ · Traditional | 12/05/1994SE |
| K911184 | Scanlan/Taheri ValvulotomeMGZ · Traditional | 02/18/1992SE |
| K864920 | Scanlan (TM) Instrument TrayFSM · Traditional | 01/12/1987SE |
| K864919 | Scanlan (TM) Vein/Graft HolderKPK · Traditional | 01/12/1987SE |
| K841521 | Scanlan EndarsectorDWX · Traditional | 08/03/1984SE |
| K841513 | Scanlan Atraum Instrument Jaw Cover · Traditional | 07/06/1984SE |
| K841085 | Scanlan Colormark Skin MarkerFZZ · Traditional | 06/11/1984SE |
| K841515 | Scanlan Vascu-Statt IIHRG · Traditional | 06/05/1984SE |
| K841514 | Scanlan Vascu-Statt II ApproximatorHRQ · Traditional | 06/05/1984SE |
Questions and answers
When was Scanlan Tunneler, Sheath & Tip cleared by the FDA?
Scanlan Tunneler, Sheath & Tip (K851825) received a 510(k) decision of Substantially Equivalent on July 12, 1985, 77 days after the submission was received.
What is the product code of K851825?
The FDA product code is DWS – Instruments, Surgical, Cardiovascular, a Class I (low risk) device regulated under 21 CFR 870.4500.