FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-RX, PAD6EK-F AND PAD6EK-FX

K964663 · Rmds, Inc. · DXC · Dec 11, 1997 · Cardiovascular

Device Facts

• Record ID: K964663
• Device Name: FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-RX, PAD6EK-F AND PAD6EK-FX
• Applicant: Rmds, Inc.
• Product Code: DXC · Cardiovascular
• Decision Date: Dec 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FAVP: Femoral Artery Vascular Pad is used to provide pressure hemostasis following femoral catheterization procedures.

Device Story

Femoral Artery Vascular Pad (FAVP) provides mechanical pressure to femoral artery access sites post-catheterization. Device functions as a manual or mechanical compression aid to achieve hemostasis. Used in clinical settings (e.g., cath lab, recovery) by healthcare professionals. Output is sustained localized pressure; facilitates clot formation; reduces risk of hematoma; assists in patient recovery post-procedure.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical pressure pad; non-powered; dimensions/materials not specified in document.

Indications for Use

Indicated for patients undergoing femoral catheterization procedures requiring pressure hemostasis at the access site.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Rockville MD 20857
DEC 11 1997

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

Re: K964663
Femoral Artery Vascular Pad - Model Number PAD2
Regulatory Class: II (two)
Product Code: DXC
Dated: September 7, 1997
Received: September 16, 1997

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 registration, 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket 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 regulation 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, 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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11/18/96
Document Number A892058

# 18 Indications for Use Statement:

510(k) Number (if known): K964663

Device Name: **FAVP: Femoral Artery Vascular Pad**

Indications For Use:

The FAVP: Femoral Artery Vascular Pad is used to provide pressure hemostasis following femoral catheterization procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑
OR
Over-The-Counter Use ☐

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Cardiovascular Research
and Neurological Services
510(k) Number K964663

RMDS, Inc. * Delbert L. Rice * 1208 SE 104th Avenue * Vancouver * WA * 98664-4740
1-360-256-8623 * 1-360-256-8623 FAX
A892058.DOC