Vascular Clamp
FDA 510(k) K874959 · Solway, Inc.
510(k) numberK874959
Submission
- Device name
- Vascular Clamp
- Applicant
- Solway, Inc.
Hollywood, FL, US - Received
- December 2, 1987
- Decision date
- December 30, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HXD – Clamp
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HXD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K890381 | Parametrium ClampHXD · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K890372 | Intestinal ClampHXD · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K890371 | Intestinal Crushing ClampHXD · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K890368 | Kidney ClampHXD · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K872386 | C ClampHXD · Traditional | Med-Tool, Inc. | 07/02/1987SE |
| K863653 | Suction-OffHXD · Traditional | B&B Medical Technologies, Inc. | 10/07/1986SE |
| K853538 | Cannula ClampHXD · Traditional | Cp Medical | 09/12/1985SE |
| K851654 | Omnimed ClampHXD · Traditional | Omni Intl., Inc. | 05/31/1985SE |
| K801819 | Surgical InstrumentsHXD · Traditional | Robert I. Chien & Assoc., Inc. | 08/20/1980SE |
| K801028 | Rica or Smic Surgical InstrumentsHXD · Traditional | Robert I. Chien & Assoc., Inc. | 05/20/1980SE |
More from Robert I. Chien & Assoc., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K874960 | Cardiovascular Surgical InstrumentsDWS · Traditional | 02/05/1988SE |
| K874962 | Forceps Cliprack Ventricular Cannula Saws SpatulasHAO · Traditional | 02/02/1988SE |
| K874956 | Self-Retaining Retractor for NeurosurgeryGZT · Traditional | 01/28/1988SE |
| K874964 | Dental Hand InstrumentsEKJ · Traditional | 01/27/1988SE |
| K875043 | Rongeur (Neurosurgical Instruments)HAE · Traditional | 01/22/1988SE |
| K874966 | Tuning ForksGWX · Traditional | 01/04/1988SE |
| K874965 | Manual Surgical Instruments for General UseHTD · Traditional | 12/30/1987SE |
| K874961 | Bone Cutting Instruments & AccessoriesGDR · Traditional | 12/30/1987SE |
| K874954 | Manual RongeurHTX · Traditional | 12/30/1987SE |
| K874952 | Manual Cranial Drill, Burr, Trephine & AccessoriesHBG · Traditional | 12/30/1987SE |
Questions and answers
When was Vascular Clamp cleared by the FDA?
Vascular Clamp (K874959) received a 510(k) decision of Substantially Equivalent on December 30, 1987, 28 days after the submission was received.
What is the product code of K874959?
The FDA product code is HXD – Clamp, a Class I (low risk) device regulated under 21 CFR 878.4800.