FDA 510(k)

#335-01 SILIC RUB ISOLA SLEEVE FOR INT #281-03 SIZ

K-Number: K853034 · 1985-07-25

Decision Date1985-07-25

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

#335-01 SILIC RUB ISOLA SLEEVE FOR INT #281-03 SIZ is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics, Inc.. It received FDA 510(k) clearance on 1985-07-25 under 510(k) number K853034. 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 #335-01 SILIC RUB ISOLA SLEEVE FOR INT #281-03 SIZ?

#335-01 SILIC RUB ISOLA SLEEVE FOR INT #281-03 SIZ is a medical device that received FDA 510(k) clearance on 1985-07-25. The listed applicant is Intermedics, Inc.. The 510(k) number is K853034.

When did #335-01 SILIC RUB ISOLA SLEEVE FOR INT #281-03 SIZ receive FDA 510(k) clearance?

#335-01 SILIC RUB ISOLA SLEEVE FOR INT #281-03 SIZ received FDA 510(k) clearance on 1985-07-25, under 510(k) number K853034.

Who is the listed applicant for #335-01 SILIC RUB ISOLA SLEEVE FOR INT #281-03 SIZ?

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

What is the FDA product code for #335-01 SILIC RUB ISOLA SLEEVE FOR INT #281-03 SIZ?

The FDA product code for #335-01 SILIC RUB ISOLA SLEEVE FOR INT #281-03 SIZ is DXY. This falls under the Clinical Chemistry category.

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Other records listing Intermedics, Inc. as applicant

K954610MODEL 430-07 ENDOCARDIAL PACING LEAD K955122INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD K962174BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)K955550CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD K960281IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY K954719INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD

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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

View on FDA Database →

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