Phrenic Nerve Pad & Nerve Pad W/1/4 Percardial
FDA 510(k) K890707 · Dlp, Inc.
510(k) numberK890707
Submission
- Device name
- Phrenic Nerve Pad & Nerve Pad W/1/4 Percardial
- Applicant
- Dlp, Inc.
Grand Rapids, MI, US - Received
- February 10, 1989
- Decision date
- April 10, 1989
- 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 |
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| 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 |
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| 510(k) | Device | Decision |
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| K973485 | Clearview Blower/MisterFQH · Traditional | 12/08/1997SE |
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| K953945 | Retrograde Coronary Sinus Perfusion Cannula with Elongated & Treaded Cuff & Introducer…DWF · Traditional | 03/26/1996SE |
| K950754 | Macro Suction Tube Model No 10061GCY · Traditional | 04/25/1995SE |
| K934215 | Contain-OrKKX · Traditional | 02/09/1994SE |
| K915268 | Catheter Two Stage Venous ReturnDWF · Traditional | 07/27/1992SE |
| K914608 | Breast Les Local Wire St. 48219/49220/48119/48120GAA · Traditional | 01/09/1992SE |
| K913077 | Lancaster Cooling Jacket, Cat. Code #13500/13501DTR · Traditional | 01/09/1992SE |
| K913098 | Apiration Biopsy Syringe Gun, Cat. Code #54501KNW · Traditional | 11/05/1991SE |
| K912229 | Ima Electrocautery Electrode Cat. #60002/60003GEI · Traditional | 09/25/1991SE |
Questions and answers
When was Phrenic Nerve Pad & Nerve Pad W/1/4 Percardial cleared by the FDA?
Phrenic Nerve Pad & Nerve Pad W/1/4 Percardial (K890707) received a 510(k) decision of Substantially Equivalent on April 10, 1989, 59 days after the submission was received.
What is the product code of K890707?
The FDA product code is DWS – Instruments, Surgical, Cardiovascular, a Class I (low risk) device regulated under 21 CFR 870.4500.