FDA 510(k)

MODEL 1000 APC-ANGIOPLASTY PRESSURE

K-Number: K841493 · 1984-06-11

Decision Date1984-06-11

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODEL 1000 APC-ANGIOPLASTY PRESSURE is the device name listed in this FDA 510(k) record. The listed applicant is E.A. Fischione Instrument Mfg.. It received FDA 510(k) clearance on 1984-06-11 under 510(k) number K841493. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 1000 APC-ANGIOPLASTY PRESSURE?

MODEL 1000 APC-ANGIOPLASTY PRESSURE is a medical device that received FDA 510(k) clearance on 1984-06-11. The listed applicant is E.A. Fischione Instrument Mfg.. The 510(k) number is K841493.

When did MODEL 1000 APC-ANGIOPLASTY PRESSURE receive FDA 510(k) clearance?

MODEL 1000 APC-ANGIOPLASTY PRESSURE received FDA 510(k) clearance on 1984-06-11, under 510(k) number K841493.

Who is the listed applicant for MODEL 1000 APC-ANGIOPLASTY PRESSURE?

The FDA 510(k) record lists E.A. Fischione Instrument Mfg. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 1000 APC-ANGIOPLASTY PRESSURE?

The FDA product code for MODEL 1000 APC-ANGIOPLASTY PRESSURE is DXT.

Related Clinical Trials

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.

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Other records listing E.A. Fischione Instrument Mfg. as applicant

K853136MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER)

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Official Source

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