Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4650](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4650) → KPK — Marker, Ostia, Aorto-Saphenous Vein

# KPK · Marker, Ostia, Aorto-Saphenous Vein

_General, Plastic Surgery · 21 CFR 878.4650 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KPK

## Overview

- **Product Code:** KPK
- **Device Name:** Marker, Ostia, Aorto-Saphenous Vein
- **Regulation:** [21 CFR 878.4650](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4650)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **Implant:** yes

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K971966](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KPK/K971966.md) | CORONARY VEIN GRAFT TAG MARKER | Med-Edge, Inc. | Jan 26, 1998 | SESE |
| [K895369](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KPK/K895369.md) | VOSS GRAFT MARKER | Voss Medical Products | Sep 27, 1989 | SESE |
| [K864919](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KPK/K864919.md) | SCANLAN (TM) VEIN/GRAFT HOLDER | Scanlan Intl., Inc. | Jan 12, 1987 | SESE |
| [K864101](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KPK/K864101.md) | COOK (R) VEIN GRAFT RING MARKERS | Cook, Inc. | Oct 30, 1986 | SESE |
| [K801637](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KPK/K801637.md) | FLUORO-MARK RADIOPAQUE ANATOMICAL MKR. | C.R. Bard, Inc. | Aug 27, 1980 | SESE |
| [K770802](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KPK/K770802.md) | MARKERS, STAINLESS STEEL | Cardio-Surgical, Inc. | Jun 27, 1977 | SESE |

## Top Applicants

- Voss Medical Products — 1 clearance
- Scanlan Intl., Inc. — 1 clearance
- Med-Edge, Inc. — 1 clearance
- Cook, Inc. — 1 clearance
- Cardio-Surgical, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KPK](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KPK)

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