FAVC-HH: FEMORAL ARTERY VASCULAR CLAMP-HAND HELD: 1/2 & 3 POUNDS (RMDS810T/815T/820T)

K973216 · Rmds, Inc. · DXC · Nov 25, 1997 · Cardiovascular

Device Facts

• Record ID: K973216
• Device Name: FAVC-HH: FEMORAL ARTERY VASCULAR CLAMP-HAND HELD: 1/2 & 3 POUNDS (RMDS810T/815T/820T)
• Applicant: Rmds, Inc.
• Product Code: DXC · Cardiovascular
• Decision Date: Nov 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FAVC-HH: Femoral Artery Vascular Clamp-Hand Held is used to provide pressure hemostasis after the removal of arterial catheters following femoral catherterization procedures. The FAVC-HH: Femoral Artery Vascular Clamp-Hand Held is positioned prior to removal of femoral catheters and applies controlled pressure to the puncture site until hemostasis is complete.

Device Story

The FAVC-HH is a hand-held mechanical clamp designed to provide controlled pressure to the femoral artery puncture site following catheter removal. It is positioned by a clinician prior to catheter withdrawal and maintained until hemostasis is achieved. The device replaces manual compression, reducing the physical burden on the clinician and ensuring consistent pressure application to the puncture site. It is intended for use in clinical settings where femoral catheterization is performed.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hand-held mechanical clamp; manual operation; non-powered; designed for external application of pressure to the femoral artery puncture site.

Indications for Use

Indicated for patients undergoing femoral catheterization procedures requiring pressure hemostasis following arterial catheter removal.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol resembles a stylized caduceus, with three intertwined lines representing snakes or streams, and a base that suggests a staff or foundation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 25 1997

Mr. Delbert L. Rice RMDS, Inc. 1208 SE 104th Avenue Vancouver, Washington 98664-4740

Re : K973216 Femoral Artery Vascular Clamp Hand Held FAVC-HH : II (two) Regulatory Class: Product Code: DXC Dated: August 25, 1997 August 27, 1997 Received:

Dear Mr. Rice:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) , it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Failure to Drug Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your premarket the Federal Register. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Čallahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement: 18

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

## Device Name: FAVC-HH: Femoral Artery Vascular Clamp-Hand Held

Indications For Use:

The FAVC-HH: Femoral Artery Vascular Clamp-Hand Held is used to provide pressure hemostasis after the removal of arterial catheters following femoral catherterization procedures. The FAVC-HH: Femoral Artery Vascular Clamp-Hand Held is positioned prior to removal of femoral catheters and applies controlled pressure to the puncture site until hemostasis is complete.

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--|--------------------------------------------------------|
|--|--------------------------------------------------------|

| Prescription Use | <div> <span>✓</span> </div> |
|------------------|-----------------------------|
|------------------|-----------------------------|

| | OR | Over-The-Counter Use |
|--|----|--------------------------|
| | | (Optional Format 1-2-96) |

| | (Division Sign-Off) |
|---------------|-------------------------------------------------------------------|
| | Division of Cardiovascular, Respiratory, and Neurological Devices |
| 510(k) Number | K973276 |

RMDS, Inc. * Delbert L. Rice * 1208 SE 104th Avenue * Vancouver * WA * 98664-4740 1-360-256-8623 * 1-360-256-8623 FAX -