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FDA 510(k)

ELECATH PORTAL VEIN/BILIARY DRAIN ASSM

K-Number: K821488 · 1982-05-28

ApplicantElectro-Catheter Corp.
Decision Date1982-05-28
Product CodeKNN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ELECATH PORTAL VEIN/BILIARY DRAIN ASSM is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Catheter Corp.. It received FDA 510(k) clearance on 1982-05-28 under 510(k) number K821488. The device is classified under product code KNN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECATH PORTAL VEIN/BILIARY DRAIN ASSM?

ELECATH PORTAL VEIN/BILIARY DRAIN ASSM is a medical device that received FDA 510(k) clearance on 1982-05-28. The listed applicant is Electro-Catheter Corp.. The 510(k) number is K821488.

When did ELECATH PORTAL VEIN/BILIARY DRAIN ASSM receive FDA 510(k) clearance?

ELECATH PORTAL VEIN/BILIARY DRAIN ASSM received FDA 510(k) clearance on 1982-05-28, under 510(k) number K821488.

Who is the listed applicant for ELECATH PORTAL VEIN/BILIARY DRAIN ASSM?

The FDA 510(k) record lists Electro-Catheter Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECATH PORTAL VEIN/BILIARY DRAIN ASSM?

The FDA product code for ELECATH PORTAL VEIN/BILIARY DRAIN ASSM is KNN.

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Other records listing Electro-Catheter Corp. 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.

K934785MULTIPACEK943257TIP DEFLECTOR (GENESIS)K933451OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATIONK933450CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATIONK934787SILICORE SEMI-FLOATERK874154ELECATH(R) TRANSESOPHAGEAL PACING CATHETER

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Related Devices (Code: KNN)

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.

K211919KISS Dynamic Back Support, KISS Dynamic Solid Drop SeatKinetic Innovative Seating System, LLCK942309DYNASTY U1-31 (GELL/CELL)Foley & LardnerK942311DYNASTY U1-33 AGMFoley & LardnerK942308DYNASTY GC 12400 (GELL/CELL)Foley & LardnerK942310DYNASTY GC 12550 (GELL/CELL)Foley & LardnerK942312ALDEN LINEAGE WHEELCHAIR CUSHIONLewis W. Ward

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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