FDA 510(k)

MODIFICATION OF STERILITY CYCLE PARAMETERS

K-Number: K863365 · 1986-10-08

Decision Date1986-10-08

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODIFICATION OF STERILITY CYCLE PARAMETERS is the device name listed in this FDA 510(k) record. The listed applicant is Coratomic, Inc.. It received FDA 510(k) clearance on 1986-10-08 under 510(k) number K863365. The device is classified under product code DXY. It was reviewed by the CV advisory panel. Product code DXY falls under the category of Clinical Chemistry, which covers reagents and instruments for chemical analysis of clinical samples. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION OF STERILITY CYCLE PARAMETERS?

MODIFICATION OF STERILITY CYCLE PARAMETERS is a medical device that received FDA 510(k) clearance on 1986-10-08. The listed applicant is Coratomic, Inc.. The 510(k) number is K863365.

When did MODIFICATION OF STERILITY CYCLE PARAMETERS receive FDA 510(k) clearance?

MODIFICATION OF STERILITY CYCLE PARAMETERS received FDA 510(k) clearance on 1986-10-08, under 510(k) number K863365.

Who is the listed applicant for MODIFICATION OF STERILITY CYCLE PARAMETERS?

The FDA 510(k) record lists Coratomic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION OF STERILITY CYCLE PARAMETERS?

The FDA product code for MODIFICATION OF STERILITY CYCLE PARAMETERS is DXY. This falls under the Clinical Chemistry category.

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Other records listing Coratomic, Inc. as applicant

K822791CORATOMIC #VX5-105 & VX5-205 PULSE GEN.K820939C-101-P K821014CORATOMIC MODEL OVALITH 920BP K821033CORATOMIC MODEL OVALITH-920 K810808CORATOMIC MODEL OVALITH-920 K802689L-15T ENDOCARDIAL PACING ELECTRODE

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Related Devices (Code: DXY)

K993434PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-ABiotronik, Inc.K970072OPUS S MODEL 4121 AND 4124 PACEMAKERSEla Medical, Inc.K945627PIKOS LP 01, PIKOS LP E01Biotronik, Inc.K953866MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)Medtronic Vascular K954092ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)Medtronic Vascular K953417MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORSCook Pacemaker Corp.

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.