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FDA 510(k)

PHARMASEAL OVER-THE NEEDLE ARTERIAL CATHETER & STA

K-Number: K853714 · 1986-01-13

ApplicantAmerican Pharmaseal Div. Ahsc
Decision Date1986-01-13
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PHARMASEAL OVER-THE NEEDLE ARTERIAL CATHETER & STA is the device name listed in this FDA 510(k) record. The listed applicant is American Pharmaseal Div. Ahsc. It received FDA 510(k) clearance on 1986-01-13 under 510(k) number K853714. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHARMASEAL OVER-THE NEEDLE ARTERIAL CATHETER & STA?

PHARMASEAL OVER-THE NEEDLE ARTERIAL CATHETER & STA is a medical device that received FDA 510(k) clearance on 1986-01-13. The listed applicant is American Pharmaseal Div. Ahsc. The 510(k) number is K853714.

When did PHARMASEAL OVER-THE NEEDLE ARTERIAL CATHETER & STA receive FDA 510(k) clearance?

PHARMASEAL OVER-THE NEEDLE ARTERIAL CATHETER & STA received FDA 510(k) clearance on 1986-01-13, under 510(k) number K853714.

Who is the listed applicant for PHARMASEAL OVER-THE NEEDLE ARTERIAL CATHETER & STA?

The FDA 510(k) record lists American Pharmaseal Div. Ahsc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHARMASEAL OVER-THE NEEDLE ARTERIAL CATHETER & STA?

The FDA product code for PHARMASEAL OVER-THE NEEDLE ARTERIAL CATHETER & STA is DQY.

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Other records listing American Pharmaseal Div. Ahsc as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K874022PHARMASEAL WOUND IRRIGATION DEVICEK874517PHARMASEAL RUBBER URETHRAL CATHETERK874045PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWERK873359AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVEK872228PHARMASEAL ALTERNATING PRESSURE PAD SYSTEMK872917JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER

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Related Devices (Code: DQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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